Sunday, January 26, 2020

Walmart: Internal and External Analysis

Walmart: Internal and External Analysis Founded in 1962 by Sam Walton, Wal-Mart Stores Inc. is one of the pioneers of discount retailing, along with Kmart and Target. Wal-Mart in US has been solely responsible for selling 35 per cent of all pet food, 24 per cent of all toothpaste, the largest volume of jewellery, groceries, DVDs, CDs, toys, guns, diapers, sporting goods, bedding and much, much more (Ramaswamy, 2004 cited in Hanson, 2008, p. 580-581). The companys success has resulted in many constantly observing it for new wisdom on management and strategy. But the recent years proved to be challenging for Wal-Mart as analysts are doubtful of the companys ability to maintain the pace of growth that it has shown in the previous years. Wal-Mart has to face competition from big players like Carrefour, Metro and Tesco as well as new entrants such as Dollar General. Besides that, Wal-Mart has taken advantage of its massive base of power to force suppliers to do more for less. Employees are also dissatisfied with the companys lack of employee welfare. External Environment Wal-Mart is one of the major players in the retailer industry. It has its own store brands in addition to selling the national brands in US. Being the main retailer in US, it has garnered enough power to negotiate the prices with the suppliers. Recently, it has an image issue due to the lawsuits it is facing, the loss of jobs indirectly linked to it as well as the declaration of bankruptcy or the shutting down of many retailers and manufacturer. Sociological Factors The giant retailer has been accused of paying its employees as low as US$8.23 which amounted being below the federal poverty line for a family of three. The company has also been sued for forcing its employees to work overtime for free. Another lawsuit against Wal-Mart is about the discrimination of women in top management. While about 90 per cent of Wal-Mart associates are women, only 15 per cent are in the top management positions. It is also suggested that Wal-Mart may be hiring illegal immigrants in violation of the law. Ethical Factors Wal-Mart is such a powerful company that its decisions will have a direct impact on all its suppliers and might even result in them filing for bankruptcy or shutting down, causing thousands to lose their jobs. In an ethical way, the retailer does not weigh the consequences or try to reduce the impact as long as the decision is beneficial to itself. Industry Environment Potential Threats of Substitutes Small -scale retailers such as Dollar General which catered to the low-income customers are proving to be among the companies that Wal-Mart needs to be wary of. While the target market seems to be the fastest growing segments of the population in US, the suppliers are also generally satisfied working with Dollar General, as compared to Wal-Mart and its suppliers. Intensity of Rivalry (International Market) Penetrating into the international market has been quite difficult for Wal-Mart because it is not as powerful and reputable as it is in US, unlike the major international players such as Carrefour, Metro and Tesco. There are more competitors that Wal-Mart has to face in the international market. Competitor Current Strategies Competitors like Carrefour are using their longer experience in the international market to their advantage. Carrefour has been accused of leaning on suppliers to choke Wal-Marts supply lines. Another strategy Carrefour employs is to demonstrate a new variation of the Everyday Low Price where its employees are found in Wal-Marts parking lots to distribute fliers, showing price comparisons with the prices at Wal-Mart at an almost real-time basis. Assumptions Major retail players like Carrefour and Tesco believe that they have the upper-hand in the international market as they are more experienced and understand the markets better. Besides that, they already have established reputations among the suppliers and will be more credible as a retailer as compared to Wal-Mart. Internal Environment Reputation with Customers By providing low prices for customers especially those living in the rural areas, many are grateful that they can save up. In addition, Wal-Mart has become so powerful that it is able to sell well-known brands at lower prices and thus proving the superior value it brings to its customers. Capabilities Wal-Mart is equipped with first-hand information about consumer preference data by having suppliers to attach remote frequency devices (RFID) technology in all their packaging to track individual items sold in the store. To improve efficiency of all business transactions with the suppliers, Wal-Marts suppliers also have to an electronic data interchange (EDI) called Retail Link that will track all business transactions with the giant retailer. Core Competency In the recent years, most of the sales of more than 30,000 suppliers are done through Wal-Mart and this puts the retailer in a very favourable position for negotiation of the prices of the products. With great foresight about the retail industry, the company is always ahead of the rest especially in terms of efficiency and delivering its promise to its customers. Stakeholders of Wal-Mart Suppliers The suppliers have become over- reliant on Wal-Mart and need the retailer more than the retailer needs them. Thus when Wal-Mart is determining the prices and thus drawing out significant price concessions from its suppliers, they are willing to comply and absorb any additional prices to make the giant retailer appease. Besides that, the suppliers also have to meet the terms set by Wal-Mart, such as the automated technology demands to have the Retail Link for their business dealings with Wal-Mart and the RFID technology in all their packaging. Suppliers are also expected to show up just when they are needed in the case of deliveries as they will be due for payment for any delivery that they miss or delay. Employees Employees have sued Wal-Mart for numerous reasons, showing their dissatisfactions with the company. Wal-Mart has been accused of making the employees work overtime without any allowance, paying low wages and involved in unfair labour practice against women in separate occasions. SWOT (S)trengths Has its own logistics as well as its own trucks and a private satellite A systematic and controlled management practice with the suppliers First-hand data about customer preference, more insight into the target market (W)eaknesses Wal-Marts image problem where the supplier are intimidated by it Ignores price increase- resulted in the suppliers shutting down, be forced into a merger/ transfer the production overseas Indirectly linked to thousands losing their jobs (O)pportunities Wal-Mart as a willing teacher, constantly educating the suppliers with new technique to tackle cost control and efficiency more would be ready to work with it (T)hreats Unreliable employees because of how they are treated by Wal-Mart Upstart chains like Dollar General contesting Wal-Marts position in the US retail market Review of Present Situation Though Wal-Mart is a powerful retailer in US and around the world, it does not maintain a positive image with its suppliers and the public. It may be looked upon in cases where people analyse its success but people may remember the negative aspects of the company better. Recommendations Create a positive image of Wal-Mart To avoid being blamed for all the jobs lost when a supplier could not live up to Wal-Marts expectations, the retailer should try to such situations whenever it can. For example, it could compromise with a supplier regarding the prices of the stocks when the prices increase. Other than that, it can donate to charitable organisations as a way of showing that the retailer also cares and gives back to the society. Wal-Mart could also create a fund to aid jobless people until they get another job. Gain employees loyalty References Ramaswamy, K. (2004). Wal-Mart Stores Inc.: Dominating Global Retailing. In D. Hanson, P. J. Dowling, M. A. Hitt, R. D. Ireland R. E. Hoskisson (Eds.) Strategic Management: Competitiveness Globalisation (pp. 577-590). Australia: Cengage Learning Australia. Tsao, A. (2003, September 26). Wal-Marts Stock: No Bargain Here. BusinessWeek Online. Retrieved from http://www.businessweek.com/bwdaily/dnflash/sep2003/nf20030929_9676_db014.htm What Influenced Georgian Style and its Features? What Influenced Georgian Style and its Features? Introduction Georgian style is a style in the architecture, interior design, and decorative arts of Britain during the 17th and 18th centuries. The term â€Å"Georgian† gets its name from four kings of England who reigned in Britain from 1714-1830. All of them were named George. (DesignIntuit, 2001) Although the George did not have an impact on the style, they perpetuated a movement that is different from the popular Italian and French Baroque style. â€Å"Georgian is a term usually associated in the popular mind with refined furniture, elegant clothes, buildings of deceptive simplicity, classical music, decorous prose, and country houses set in pleasing parks.† (Georgian Housestyle, Ingrid Cranfield). In essence, Georgian is not a style by itself, but an era during that many developments and changes happened in both architecture and interior design. (Worldguide, 2015) Early Georgian style: Influence of classicism Each architect or designer has his own ideas and individual approach. However, all of them had something common: they were heavily influenced by elements of ancient Rome and Greece. In other words, they were driven by the same motivated idea: to recreate the antique classical world. Classicism was considered as godlike: it reproduced the building blocks of God’s creation and the accords of nature. Furthermore, this (Georgian) period is defined as â€Å"an era of refined neoclassical trends†. (Worldguide, 2015) As it was mentioned earlier, the Georgian style was highly influenced by classicism. Young British aristocrats (including architects, designers and furniture makers) in the 17th and 18th centuries took the â€Å"Grand Tour† of European countries. These â€Å"Grand Tours† made the influential classes follow classical traditions of architecture and design. However, the Baroque used classical ornamentation and decor in a very open ended way. (David Ross, 2015) However, the British employed these motifs in an inflexible and calm way. (Worldguide, 2015) If Baroque is too much, Georgian classicism is a grace. Early Georgian style: Influence of Palladinism Besides classicism, there was another style that had a very strong impact on the Georgian style. It is a Palladinism, â€Å"a philosophy of design based on the writings and work of Andreas Palladio†. (David Ross, 2015) He is an Italian architect of the 16th century who recreated the design and proportions of the buildings of antique Rome. (Worldguide, 2015) Famous English architect Inigo Jones brought the Georgian style to Britain in the 17th century. (Worldguide, 2015) Palladinism was a significant factor in the early Georgian style. There was a proportion-based Palladian school of design that dominated British architecture from the mid-1720s to the early 1750s. It was rich and graceful, and there were Roman temple facades and pillars. In addition, a mathematical formulae was used for a building’s proportion. However, after 1750 (Dan Cruickshank, 2011) or from around 1760 (Worldguide, 2015), English architects James Stuart, Sir William Chambers and Scottish architect Robert Adam were exposed to a clearer style of classicism around Britain. They were inspired by the archaeological discoveries at Pompei and Herculanium. This new information about Greek and Roman architecture brought about a neoclassical revolution in taste. This emphasises on neoclassicism that became more widespread for design for the duration of the mid-Georgian period, which was until 1800 (Dan Cruickshank, 2011). Early Georgian style: Examples James Stuart One of the best examples of neoclassicism is James Stuart (1713-1788). He went on various â€Å"Grand Tours† of many European cities like other architects at that time. While he was studying in Greece, his work was inevitably influenced by clear Greek motifs. Due to these studies, he got the nickname â€Å"Athenian† Stuart. In addition, he published â€Å"Antiquities of Athens† in separate books from 1762. (Worldguide, 2015) On the picture below shows an example of his work: (St James’s Square, London) Sir William Chambers Sir William Chambers (1723-1796) is one of the architects representing the mid-Georgian period. He was born in Sweden to Scottish parents. His architectural practise was in London in the 1750s. Moreover, Sir William spent time in China, which gives an explanation why his neoclassicism was mixed with Chinese touches and elements. The name of the technique is known as chinoiserie, and it enjoyed modest popularity in Britain that time. He also showed Greek and Roman characteristics of French neoclassicism. (Worldguide, 2015) (Chinese Pagoda in Kew Gardens, London and Somerset House, London) Robert Adam One more example is Robert Adam (1728-1992). He was born in Fife, Scotland. He worked with his brother James on a style airier than the Palladian, using Egyptian and Gothic motifs with Roman decorations. His artworks were symmetrical but not as much as Palladian proportions. Furthermore, he was known to show motifs as â€Å"ribbons, wreaths, sphinx and griffins, ovals and hexagons etc†. This style was famous as the Adam style. (Worldguide, 2015) (Syon House, West London) Late Georgian style Late Georgian style is known as Regency and was popular during the reign of the British Prince Regent from 1811 to 1820. (The Editors of Britannica, 2015 and Worldguide, 2015) Actually, the Regency style recollected neoclassical elements, but it was opened more to Greek, Egyptian, Asian and French influences than it was before. This style is much heavier in ornamentation than earlier Georgian styles, and building facades were often covered with stucco plaster than noticeable brick. Moreover, interiors were more open and light, and windows became larger. In my personal opinion, the Regency style (Late Georgian style) is akin to a bridge between early Georgian design and approaching Victorian era. Henry Holland For instance, Henry Holland (1745-1806) was the most leading architect of the late Georgian period. (Worldguide, 2015) Holland’s designs was influenced by Roman, Greek and Egyptian forms and the Empire styles of late 18th century France as well. His style is simpler and more academic. (Sloane Street and Sloane Square, West London) Features of Georgian style Landscape There are many characteristics defining the Georgian period. One of the main features is terrace. The 18th century (David Ross, 2015) was a time of great success of urban developments. Houses had a public and private function. Unfortunately, it meant that there was a need to put a lot of houses into a small space. It lead to the creation of the terrace. The terrace allowed a whole street to have a sense of architectural completeness, also keeping small sizes of houses. Terraces used to take a few forms; typically laid out in straight lines or in quadrangles around a central garden area, or in curves or oval â€Å"circuses†. In addition, these developments gave birth of the townhouses practical housing built in lengthy, well-ordered terraces, which made boulevard look like neat architectural elements. (Worldguide, 2015) These townhouses were usually four levels in height and made of brick. However, during that period (18th century) the rich were increasingly wealthier and as a result, they began investing money into their households. Wealthy landlords used their huge land to create designed parks, and those parks were called â€Å"country houses†. (David Ross, 2015) These estates were full of reproductions of classical temples and additional architectural pieces: grottoes, bridges, and that group of fragments called â€Å"follies†. Basically, these parks carried on the classical philosophy. Architecture Furthermore, there are other common architectural elements, such as symmetrical form, classical entrances, glass fanlights, large four-sided rooms, sash windows, huge exterior symmetrical stairways, internal hall stairway, pediment door and geometric decorations. (DesignIntuit, 2001) Shape is a main significant feature of this style. The square is â€Å"prominent† (DesignIntuit, 2001), and shapes are classical. The foundation of Georgian proportion was usually geometrical, with the central block of the building â€Å"often augmented by hyphens and wings† (Wentworthstudio, 2015) Homes were only symmetrical. There was not usually an even number of windows (five across for house). This did not allow asymmetry around the middle window of the building. Sash windows –â€Å"panes divided by wooden bars† (Worldguide, 2015) – were common. In addition, windows were quadrilateral (DesignIntuit, 2001) and had the same width (Worldguide, 2015). However, their height was various from the first floor to the last one. Second floor windows were the tallest ones, while ground floor and third floor windows were shorter, and the windows on the top were almost four-sided. Every Georgian house door is groundwork and supported by monuments. (DesignIntuit, 2001) There was a window on the top of the door, and it was separated by a structure called a transom. (Worldguide, 2015) There was typically a hip roof, sometimes with dormers. It was very popular with Christopher Wren. Moreover, a more asymmetrical gable roof would be inappropriate at all. (Wentworthstudio, 2015) Interior design and decorative arts In the Georgian period, there was a significant rise in popularity with regards to interior decoration. (Britannica,2015) When you look at Georgian interiors, think about those architectural elements that are inside – large furnace and doorways, and well-balanced proportioned rooms. In addition to architecture and interior design, there were great achievements in the decorative arts. For instance, furniture design met many styles and approaches, ranging from the classical influence, to the straight and simple lines etc. Conclusion Sadly, that period could not last. Victorian morality transformed architecture and other designs because their idea was about adopting gothic style as a national one due to the fact that it was a native design for the Great Christian Empire of Britain. (Dan Cruickshank, 2011) To sum up, the Georgian period, especially architecture left many masterpieces and a variation of styles and ideas. Moreover, the cities and urban quarters created that time (Bath and Bloomsbury in London) are still models of comfortable urban living. Bibliography â€Å"Georgian Style†, David Ross, 2015 (http://www.britainexpress.com/architecture/georgian.htm) â€Å"The Georgian Style of British Colonial Annapolis†, DesignIntuit, 2001 (http://www.designintuit.com/issue0002/focus/ghistory.html) â€Å"The Georgian Era of Great Britain†, Worldguide, 2015 (http://www.worldguide.eu/wg/index.php?StoryID=148ArticleID=21368) â€Å"Georgian architecture: a classical re-education†, Dan Cruickshank, 2011 (http://www.theguardian.com/artanddesign/2011/sep/11/georgian-architecture-british) â€Å"Historic styles: Georgian style†, Wentworthstudio, 2015 (http://www.wentworthstudio.com/historic-styles/georgian/) â€Å"Georgian architecture†, Britannica, 2015 (http://www.britannica.com/EBchecked/topic/230322/Georgian-style) 1 Fast Dissolving Drug Delivery Systems: A Brief Overview Fast Dissolving Drug Delivery Systems: A Brief Overview 1.1 Introduction to fast dissolving drug delivery system Fast dissolving drug delivery systems have rapidly gained acceptance as an important new way of administering drugs. There are multiple fast-dissolving OTC and Rx products on the market worldwide, most of which have been launched in the past 3 to 4 years. There have also been significant increases in the number of new chemical entities under development using a fast-dissolving drug delivery technology. Rapidly dissolving dosage forms have acquired great importance in the pharmaceutical industry because of their unique properties. Rapidly dissolving dosage forms are also called quick-dissolving delivery systems; quick-disintegrating, orally disintegrating, mouth dissolve dosage forms; or melt-in-mouth dosage forms. However, the function and concept of all these dosage forms are similar. In less than one minute, these dosage forms disintegrate or dissolve in the salivary fluids of the oral cavity, releasing the drug and inactive ingredients. Most of the drug is swallowed with the saliva where subsequent absorption takes place in the gastrointestinal tract. By definition, a solid dosage form that dissolves or disintegrates quickly in the oral cavity, without the need for the administration of water, is known as an oral fast-dissolving dosage form. Salient Features of Fast Dissolving Drug Delivery System Ease of administration for patients who are mentally ill, disabled and uncooperative. Requires no water Quick disintegration and dissolution of the dosage form. Overcomes unacceptable taste of the drugs. Can be designed to leave minimal or no residue in the mouth after administration and also to provide a pleasant mouth feel. Allows high drug loading. Ability to provide advantages of liquid medication in the form of solid preparation. Adaptable and amenable to existing processing and packaging machinery Cost- effective [5-9]. 1.2 Characteristics of Fast Dissolving Delivery System [5] 1.2.1 Ease of administration Fast Dissolving Delivery Systems are easy to administer and handle hence, leads to better patient compliance. Usually, elderly people experience difficulty in swallowing the conventional dosage forms (tablets, capsules, solutions and suspensions) because of tremors of extremities and dysphasia. Fast Dissolving Delivery Systems may offer a solution for these problems. 1.2.2 Taste of the medicament As most drugs are unpalatable, mouth dissolving delivery systems usually contain the medicament in taste masked form. Delivery systems dissolve or disintegrate in patients mouth, thus releasing the active ingredients which come in contact with the taste buds and hence, taste masking of the drugs becomes critical to patient compliance. 1.2.3 Hygroscopicity Several fast dissolving dosage forms are hygroscopic and cannot maintain physical integrity under normal condition from humidity which calls for specialized product packaging [10].  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   1.2.4 Mouth feel Mouth feel is critical, and patients should receive a product that feels pleasant. Any large particles from the disintegrating tablet that are insoluble or slowly soluble in saliva would lead to an unpleasant gritty feeling. This can be overcome by keeping the majority of the particles below the detectable size limit. In some cases, certain flavors can imbibe an improved mouth feel perception, resulting in a product that is perceived as being less gritty, even if the only change is the flavor. Effervescence can be added to aid disintegration and improve mouth feel by reducing the dryness of a product [11, 12]. 2. Introduction to fast dissolving oral thin film. 2.1 Definition Thin film drug delivery is a process of delivering drugs to the systemic circulation via a thin film that dissolves when in contact with liquid, often referred to as a dissolving film or strip. Thin film drug delivery has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with prescription and OTC medications. Similar in size, shape and thickness to a postage stamp, thin film strips are typically designed for oral administration, with the user placing the strip on or under the tongue or along the inside of the cheek. As the strip dissolves, the drug can enter the blood stream enterically, ducally or sublingually. The first commercial non-drug product to use thin films was the Listerine PocketPaks breath freshening strips. Since then, thin film products for other breath fresheners, as well as a number of cold, cough, flu and anti-snoring medications, have entered the marketplace. There are currently several projects in development that will deliver prescription drugs utilizing the thin film dosage form [13]. 2.2 Advantages of fast dissolving oral thin film The design of thin film, often referred to as Pharm Film, as an oral drug delivery technology offers several advantages over other modes of drug delivery, such as ingestible tablets, chewable tablets, orally dissolving tablets, softgels, liquids or inhalants[14]. The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing, and enhance the efficacy and safety profile of the medicament. All tablet dosage forms, softgels and liquid formulations primarily enter the blood stream via the gastrointestinal tract, which subjects the drug to degradation from stomach acid, bile, digestive enzymes and other first pass effects. As a result, such formulations often require higher doses and generally have a delayed onset of action. Conversely, buccal and sublingual thin film drug delivery can avoid these issues and yield quicker onsets of action at lower doses. Thin film is more stable, durable and quicker dissolving than other conventional dosage forms. Thin film enables improved dosing accuracy relative to liquid formulations since every strip is manufactured to contain a precise amount of the drug. Thin film not only ensures more accurate administration of drugs but also can improve compliance due to the intuitive nature of the dosage form and its inherent ease of administration. These properties are especially beneficial for pediatric, geriatric and neurodegenerative disease patients where proper and complete dosing can be difficult. Thin films ability to dissolve rapidly without the need for water provides an alternative to patients with swallowing disorders and to patients suffering from nausea, such as those patients receiving chemotherapy. Thin film drug delivery has the potential to allow the development of sensitive drug targets that may otherwise not be possible in tablet or liquid formulations. From a commercial perspective thin film drug delivery technology offers an opportunity to extend revenue lifecycles for pharmaceutical companies whose drug patent is expiring and will soon be vulnerable to generic competition. Advantages of Oral Thin Film Thin elegant film Convenient dosing Fast disintegration Enhance stability Quick dissolving Improve patient compliance Rapid release Life cycle management mucoadhesion Taste masking unobstructive No risk of choking Various sizes and shapes No water needed 2.3 Need for fast dissolving thin film drug development 2.3.1 Taste masking An important aspect of thin film drug delivery technology is the masking of the often bitter and poor taste of drug formulations[14].One method of taste-masking is encapsulation, the coating of drug particles with a polymeric covering sufficient to mask the taste of the drug particle while maintaining the ability to release the drug for absorption. Encapsulation is an efficient method for combining a high ratio of drug-to-non-drug elements in the taste-masked particle. Another method is the use of an ion exchange resin to bind the drug, forming a resinate that is less bitter than the drug alone. Shivang Chaudhary,final year M.S.Pharm student of Indian NAtional Institute of Pharmaceutical Education Research (NIPER) has formulated Taste masked Quick melting oral strip(QMOS) for quick onset of erection, in which they got success in bitter taste masking of sildenfil citrate via its inclusion complexation within B-Cyclodextrin by simple kneading method. 2.3.2 Drug content uniformity Drug content uniformity is a requirement for all dosage forms, particularly those containing low dose highly potent drugs. To uniquely meet this requirement, thin film formulations contain uniform dispersions of drug throughout the whole manufacturing process[15].Since this criteria is essential for the quality of the thin film and final pharmaceutical dosage form, the use of Laser Scanning Confocal Microscopy (LSCM) was recommended to follow the manufacturing process[16]. 2.3.3 Avoiding drug degradation Sensitive drugs may degrade over time in an aqueous environment. Thin film formulations must ensure that the integrity of the drug remains constant over time [17]. To overcome these challenges, developers of thin film have created highly specialized unique and often proprietary processes to deliver drugs on thin film [18]. 2.4 Functionality of oral thin film Pharmaceutical companies and consumers alike have embraced OTFs as a practical and accepted alternative to traditional OTC medicine forms such as liquids, tablets, and capsules. OTFs offer fast, accurate dosing in a safe, efficacious format that is convenient and portable, without the need for water or measuring devices [19]. OTFs are typically the size of a postage stamp and disintegrate on a patients tongue in a matter of seconds for the rapid release of one or more APIs. The formulation of dissolvable films is customarily facilitated through aqueous polymer matrices that span a wide molecular weight (MW) range, thereby providing flexibility to achieve certain physical properties. With the selection of appropriate polymer excipients, these properties can be tailored to meet specific API-loading needs and dissolution rates. To date, the commercial launch of OTFs is primarily in OTC products addressing therapeutic categories such as cough/cold, sore throat, and antacid/gas relief as well as a number of nutritional supplement applications [19]. In compliance with the appropriate monographs, current products deliver a specified API dose that is immediately released and ingested. Some drug forms are more easily used in OTFs than others (soluble versus non soluble), but we can expect API concentrations to increase as new OTF formulations are developed. The capabilities of the base technology to create dissolvable films continue to evolve. For example, a common misconception of the OTF format is that it is limited with regard to the loading capacity of APIs. Some researchers reference a limit of 30 mg of API content as the maximum concentration. A more accurate statement would be that OTFs have the capability to load APIs up to 50% of the unit dose mass, as demonstrated by Novartis Consumer Healths Gas-X thin film, which contains 62.5 mg of simethicone per dose [20]. Some drug substances may be absorbed more rapidly through the oral mucosal and esophageal tissues via OTF formats during ingestion. Because the drug enters directly into the bloodstream and avoids hepatic first-pass metabolism, bioavailability may be improved, and the drug can be administered in smaller doses. Smaller doses translate to fewer side effects and potentially improved patient compliance. Oral mucosal delivery via OTFs could become a preferential delivery method for therapies in which rapid absorption is desired, including those used to manage pain, allergies, sleep difficulties, and central nervous system disorders. Functional film properties controlled during manufacturing Thickness Width Drug concentration residual volatiles tensile strnth disintegration rates dissolution rates 2.5 oral thin film as Strategic therapeutic categories OTF formats can be considered for any therapeutic category in which an oral solid, liquid, or ODT format is currently offered. Ideal applications are those that use drug compounds that are potent and possess a narrow therapeutic range [21]. In addition, OTFs are proven to be a more beneficial platform for compromised populations such as children or the elderly where a quick, well-tolerated platform aids administration [22]. From a strategic standpoint, a group of therapeutic categories stand out as leading applications for the OTF format to expand beyond commercial OTC products on the market today (see sidebar, Strategic therapeutic categories for oral thin films). Development of a branded prescription OTF product for smoking cessation would set a precedent for the format, much like the launch of transdermal drug delivery patches for smoking cessation did in the 1990s. Strategic therapeutic categories for oral thin films Contraception Hormone replacement Pain management Allergy and asthama Nausea Central nervous system disorders Anti-inflammatory Gastro-intestinal Sleep aids Veterinary medicines and vitamins 3. Drugs availability in market as a film/strip The use of thin-film strips is of growing interest in the pharmaceutical sector following the success of Listerine PocketPaks ® in the United States. Thin-film strip technology uses a range of water-soluble polymers and is reported to be able to incorporate watersoluble, insoluble, or taste-masked ingredients. The film is manufactured as a continuous sheet and then cut into individual doses prior to packing. The major limitations to this technology are the relatively low doses that can be accommodated (approximately 30 mg) and its moisture sensitivity thus requiring specific unit-dose packaging to protect the product and ensure shelf life. Thin-film technology has primarily been used in over the- counter (OTC) products. 4. Market trends TCIs report also details the technology programs of 25 companies active in the development of Orally-Disintegrating Tablet technologies and 17 active in the development of Oral Film technologies. Technology Catalysts forecasts the market for drug products in oral thin film formulations to be valued at $500 million in 2007 and could reach $2 billion by 2010. The first oral strip was developed by Pfizer (New York) as a mouth freshening product (Listerine pocket packs). Chloraseptic Relief Strips (distributed by Prestige Brands, Irvington, NY), Theraflu Thin Strips treat the most common symptoms of a cold in adults and children 12 and older and will be available in two cherry-flavoured treatment options: Long Acting Cough that quiets coughs for up to eight hours, and Multi-Symptom that, as well as tackling coughs, is said to provide temporary relief from a runny nose and sneezing, and soothes itchy, watery eyes and throat. Both will cost approximately $5.49 for a 12-strip pack. Meanwhile, Triaminic Thin Strips, for children ages 6-12, will also be available in two treatment options: Long Acting Cough that quiets coughs for up to eight hours, in cherry flavor, and Cough Runny Nose, in grape flavour. They will cost approximately $5.99 for a 16-strip pack, according to Novartis. 5. Formulation consideration 5.1. film forming polymer A variety of polymers are available for preparation of OS. The polymers can be used alone or in combination to obtain the desired strip properties. The film obtained should be tough enough so that there wont be any damage while handling or during transportation. The robustness of the strip depends on the type of polymer and the amount in the formulation [23]. On the other hand, fast dissolving strip dosage formshould have the property to disintegrate in seconds when placed in mouth and deliver the drug to the oral cavity instantaneously. A list of polymers and their properties are given in Table 5 [24-30]. As the strip forming polymer (which forms the platform for the OS) is the most essential and major component of the OS, at least 45%w/w of polymer should generally be present based on the total weight of dry OS [31]. Of the various polymers available, pullulan, gelatin and hypromellose are most commonly used for preparation of OS. Pullulan is a natural polymer obtained from non-animal origin and does not require chemical modification. This polymer provides highly clear and homogenous films. It has low oxygen permeability and low water content which makes it most suitable for production of OS [32]. Many times, mixtures of polymers are used to improve hydrophilicity, flexibility, mouth-feel and solubility characteristics of OS. Polyvinyl pyrrolidone films are brittle in nature and therefore copovidone is mixed with poly vinyl pyrrolidone for preparation of flexible fast disintegrating strips [33]. Combination of microcrystalline cellulose and maltodextrin has been used to formulate OS of piroxicam made by hot melt extrusion technique. In this case, microcrystalline cellulose is used to render the film non-sticky and smooth [34]. Microcrystalline cellulose was also used to decrease the disintegration time and improve the dissolution of drug from the OS [35]. Property of polymer non-toxic non-irritant devoid of leachable impurities good wetting property spreadability property readily available Should not be very expensive Should exhibit sufficient peel, shear and tensile strengths. Various polymers can be employed to modulate the disintegration property of the oral strip. This is especially used in case of slowly disintegrable oral bioadhesive strips or patches that need to be retained in intact form for longer duration in the oral cavity. The bioadhesive polymer used in such formulations imparts the adhesive property to the strip such that it adheres to buccalmucosa to deliver the drug for prolonged period. Bioadhesive polymer should ideally adhere quickly to the buccal mucosa and should have sufficient mechanical strength. Polymers used for OS should have good shelf life and they should not aid in causing secondary infections in the oral mucosa or dental regions. It would be ideal to have a polymer that would have local enzyme inhibition action along with penetration enhancing property. The details of properties of bioadhesive or mucoadhesive polymers and their applications are discussed elsewhere [36-43]. Mucoadhesive polymers include polycarbophil, cellulos e derivatives like hydroxypropyl methylcellulose, poly(acrylic acid) derivatives, sodium carboxymethyl cellulose, hydroxylethyl cellulose, hyaluronic acid, xanthan gum, locust bean gum, guar gum, carrageenan, sodiumalginate, chitosan, poly(ethylene oxide), poly (ortho esters), poly (hydroxyl butyrate), poly(cyano acrylates), polyphosphazenes, poly (vinyl alcohol) etc. Second generation mucoadhesive polymers include thiolated polymers. They are multifunctional polymers consisting of hydrophilic macromolecules having free thiol groups on the polymer backbone. The polymer forms disulfide bonds with cysteine-rich subdomains of mucus glycoproteins. Corium International has developed a new class of adhesive hydrogels (Corplex„ ¢) [44]. There are a number of marketed products available that are based on mucoadhesion phenomena. Oramoist ® is a Timed Release oral disk that adheres to the roof of the mouth and has a moisturizing effect for about 4 h [44]. It is recommended for dry mouth syndrome (xerostomia). Compeed ® is another formulation that is intended to treat cold sore [46]. Table Polymer: Hydoxy propyl methyl cellulose (HPMC) Synonym:  Methocel, Metolose,  Benecel  (Hypromellose) Description: It is a odorless, tasteless and white or creamy white fibrous or granular powder Molecular weight: 10,000-1,500,000 Solubility:  Soluble in cold water,forming a viscous colloidal  solution, insoluble in  chloroform, ethanol Polymer:  Hydroxy propyl cellulose Synonym:  Hydroxyl propyl ether,  hyprolose, Klucel, Nisso HPC. Description:  It is a white to slightly yellow  colored, odorless and  tasteless powder. It is stable  material Molecular weight:  50,000-1,250,000 Solubility:  It is freely soluble in water  below 38  °C forming a  smooth, clear, colloidal  solution. Hydroxypropyl  cellulose is soluble in many  cold and hot polar organic  solvents such as absolute  ethanol, methanol, isopropyl  alcohol and propylene glycol Polymer:  Starch and modified starch Synonym:  Amido, amylum, PharmGel,  Fluftex W, Instant pure-Cote,  Melogel etc. Description:  It is an odorless, tasteless,  fine, white powder. Molecular weight:  50,000-160,000 Solubility:  It is insoluble in cold  water and ethanol. It swells in  water by about 5 to 10% at  37  °C Polymer:  Pullulan Synonym:  Pullulane, 1, 6 ÃŽÂ ± linked  maltotriose Description:  It is available as white,  odorless tasteless, stable  powder Molecular weight:  8000-2,000,000 Solubility:  It is soluble in hot as well as  cold water Polymer:  Pectin Synonym:  Citrus pectin, Methopectin,  pectin, pectinic acid   Description:  It occurs as a yellowishwhite,  odorless powder with  mucilaginous taste. Molecular weight:  30,000-100,000 Solubility:  It is soluble in water but  insoluble in most of the  organic solvents. Polymer:  Gelatin Synonym:   Byco, cryogel, Instagel,  Solugel Description:  It occurs as light amber to  faintly yellow colored,  vitreous, brittle solid. It is  ordorless, tasteless. Molecular weight:  15,000-250,000 Solubility:  Soluble in glycerin, acid and  alkali. Swells in water and  softens. It is soluble in hot  water Polymer:  Carboxy methyl cellulose Synonym: Akulell, Blanose, Aquasorh Description:  It is white, odorless powder Molecular weight:  90,000-700,000 Solubility: It is easily dispersed in water  to form a clear or colloidal  solution 5.2 Plasticizer Plasticizer is a vital ingredient of the OS formulation. It helps to improve the flexibility of the strip and reduces the brittleness of the strip. Plasticizer significantly improves the strip properties by reducing the glass transition temperature of the polymer. The selection of plasticizer will depend upon its compatibility with the polymer and also the type of solvent employed in the casting of strip. The flow of polymer will get better with the use of plasticizer and enhances the strength of the polymer [47, 48]. Glycerol, Propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, Citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin and castor oil are some of the commonly used plasticizer excipients. Typically the plasticizers are used in the concentration of 0-20%w/w of dry polymer weight [49-57]. However inappropriate use of plasticizer may lead to film cracking, splitting and peeling of the strip [58-60]. It is also reported that the use of certain plasticizers may also affect the absorption rate of the drug [61]. 5.3 Active pharmaceutical ingredient The active substance is may be from any class of pharmaceutically active substances that can be administered orally or through the buccal mucosa, respectively. The OS technology has the potential for delivery of variety of APIs. However since the size of the dosage form has limitation, high dose molecules are difficult to be incorporated in OS. Generally 5%w/w to 30%w/w of active pharmaceutical ingredients can be incorporated in the OS [62]. Multivitamins up to 10%w/w of dry film weight was incorporated in the OS with dissolution time of less than 60 s [32]. APIs can also be added as milled, micronized or in the form of nanocrystals or particles depending upon the ultimate release profile desired. It is always useful to have micronized API which will improve the texture of the film and also for better dissolution anduniformity in the OS [63]. Some of the examples of suitable drug molecule that can be incorporated in the OS are listed in table-6. 5.4 sweetening agent Sweeteners have become the important part of the food products as well as pharmaceutical products intended to be disintegrated or dissolved in the oral cavity. Natural sweeteners as well as artificial sweeteners are used to improve the palatability of the mouth dissolving formulations. Sweetening agent such as Sugar, dextrose, lactose, mannitol, sucrose, xylitol, malitol, acesulfame potassium, talin, glycyrrhizin, sucralose, aspartame, saccharin etc. The classical source of sweetener is sucrose (derived from cane or beet in the form of liquid or dry state), dextrose, fructose, glucose, liquid glucose and maltose. The sweetness of fructose is perceived rapidly in the mouth as compared to sucrose and dextrose. Fructose is sweeter than sorbitol and mannitol and thus used widely as a sweetener. The artificial sweeteners have gained more popularity in food and pharmaceutical preparations. Saccharin,cyclamate and aspartame are the first generation of the artificial sweeteners followed by acesulfame-K, sucralose, alitame and neotame which fall under the second generation artificial sweeteners. Acesulfame-K and sucralose have more than 200 and 600 time sweetness. Neotame and alitame have more than 2000 and 8000 time sweetening power as compared to sucrose. Rebiana which is a herbal sweetener, derived from plant Stevia rebaudiana (South American plant) has more than 200-300 time sweetness [64].The flavor quality of these artificial sweeteners is different than the natural sweeteners and may not be acceptable to the patients who are accustomed to the natural sugars. The amalgamation of sweeteners may lead to synergismand improvement in the taste of the formulations [65]. Aspartame was used for the preparation of oral strips of valdecoxib [66]. For the oral strip of piroxicam, mal todextrin was employed as  sweetening agent [67]. Generally sweeteners are used in the concentration of 3 to 6 %w/w either alone or in combination [68]. 5.5 flavoring agent Perception for the flavors changes from individual to individual depending upon the ethnicity and liking. The selection of flavor is also dependant on the type of drug to be incorporated in the formulation. For example, mint flavor is generally added in products used for gastric related ailments like indigestion. The acceptance of the oral disintegrating or dissolving formulation by an individual by and large depends on the initial flavor quality which is observed in first few seconds after the product has been consumed and the after taste of the formulation which lasts for at least about 10 min [69]. Flavoring agents can be selected from synthetic flavor oils, oleo resins, extract derived from various parts of the plants like leaves, fruits and flowers. Flavors can be used alone or in the combination. Peppermint oil, cinnamon oil, spearmint oil, oil of nutmeg are examples of flavor oils while vanilla, cocoa, coffee, chocolate and citrus are fruity flavors. Apple, raspberry, cherry, pineapple are few examples of fruit essence type. The amount of flavor needed to mask the taste depends on the flavor type and its strength. Preferably up to 10%w/w flavors are added in the OS formulations. Cooling agents like monomethyl succinate can be added to improve the flavor strength and to enhance the mouth-feel effect of the product. Other cooling agents likeWS3, WS23 and Utracoll II can also be used in conjunction with flavors [68, 70]. 5.6 coloring agent Coloring agents may include FD C coloring agents, natural coloring agents, and natural juice concentrates, pigments such as titanium oxide, silicon dioxide and zinc oxide. (not exceeding concentration levels of 1%w/w) in OS .when some of the formulation ingredients or drugs are present in insoluble or suspension form [71,72]. 5.7 stabilizing and thickening agent The stabilizing and thickening agents are employed to improve the viscosity and consistency of dispersion or solution of the strip preparation solution or suspension before casting. Natural gums like xanthan gum, locust bean gum, carragenan and cellulosic derivatives can be used in the concentration up to 5%w/w as thickening agents and stabilizing agents [68]. Other ingredients such as surfactants and emulsifying agents are also added in small amount to improve the strip properties. 5.8 saliva stimulating agent The purpose of using saliva stimulating agents is to increase the rate of production of saliva that would aid in the faster disintegration of the rapid dissolving strip formulations. Generally acids which are used in the preparation of food can be utilized as salivary stimulants. Citric acid, malic acid, lactic acid, ascorbic acid and tartaric acid are the few examples of salivary stimulants, citric acid being the most preferred amongst them. These agents are used alone or in combination between 2 to 6%w/w of weight of the strip. Other OS ingredients such as sweeteners also act as salivary stimulants. Food grade sugars as well as synthetic sugars are useful salivary stimulants along with acidulents. Glucose, fructose, xylose, maltose, lactose are few examples of such sweeteners [73]. The resting salivary flow rate was 0.34 ml/min .but citric acid is capable to increase the salivary flow rate up to 1.68ml/min [73]. 6. Method of manufacturing of oral thin film One (or a combination) of the following processes may be used to manufacture the oral films [74]. Solvent casting Hot-melt extrusion Solid dispersion extrusion Rolling 6.1 Solvent Casting The oral film is preferably formulated using the solvent-casting method, whereby the water-soluble ingredients are dissolved to form a clear viscous solution. The API and other agents are dissolved in smaller amounts of the solution, and combined with the bulk. This mixture is then added to the aqueous viscous solution. The entrapped air is removed by vacuum. The resulting solution is cast as a film and allowed to dry, which is then cut into pieces of the desired size. Water-soluble hydrocolloids used to prepare films are: hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose (HPC), pullulan, sodium alginate, pectin and carboxymethyl cellulose (CMC) [75]. 6.2 Hot melt extrusion Hot melt extrusion (HME) is commonly used to prepare granules, sustained-release tablets, transderm

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