Tuesday, June 4, 2019

Walmart: Internal and External Analysis

Walmart Internal and External AnalysisFounded in 1962 by Sam Walton, Wal-Mart Stores Inc. is unmatch sufficient of the pi maveners of discount retailing, along with Kmart and Tar substantiate. Wal-Mart in US has been but responsible for interchange 35 per cent of all pet food, 24 per cent of all toothpaste, the macrost volume of je salutaryery, groceries, DVDs, CDs, toys, guns, diapers, sporting goods, bedding and much, much to a biger extent (Ramaswamy, 2004 cited in Hanson, 2008, p. 580-581). The comp alls success has resulted in many perpetually observing it for new wisdom on precaution and strategy.But the recent years proved to be contest for Wal-Mart as analysts atomic number 18 doubtful of the companys ability to entertain the pace of growth that it has constituten in the previous years. Wal-Mart has to face competition from big players like Carrefour, electron tube and Tesco as well as new entrants much(prenominal)(prenominal) as Dollar General. anyhow that, Wa l-Mart has taken advantage of its massive base of power to force suppliers to do much for less. Employees argon as well as dissatisfied with the companys lack of employee welf be.External purlieuWal-Mart is one of the study 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 equipment casualtys with the suppliers. Recently, it has an image issue due to the wooings it is facing, the loss of jobs indirectly associate to it as well as the declaration of bankruptcy or the shutting down of many retailers and manufacturer.Sociological FactorsThe giant retailer has been acc calld 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 overly been sued for forcing its employees to work overtime for free. An other lawsuit against Wal-Mart is about the discrimination of wome n in efflorescence worry. While about 90 per cent of Wal-Mart associates are women, only 15 per cent are in the top management positions. It is likewise suggested that Wal-Mart may be hiring illegal immigrants in violation of the law.Ethical FactorsWal-Mart is such a respectable company that its decisions forget fuck off 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 EnvironmentPotential Threats of SubstitutesSmall -scale retailers such as Dollar General which catered to the low-income customers are proving to be among the companies that Wal-Mart occupys to be wary of. While the target market seems to be the fastest growing segments of the population in US, the suppliers are also much often than not satisfied working with Dollar Ge neral, as compared to Wal-Mart and its suppliers.Intensity of Rivalry (International Market)Penetrating into the worldwide market has been quite difficult for Wal-Mart because it is not as powerful and reput able as it is in US, unlike the major international players such as Carrefour, Metro and Tesco. at that place are more competitors that Wal-Mart has to face in the international market.CompetitorCurrent StrategiesCompetitors 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 renewing 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.AssumptionsMajor retail players like Carrefour and Tesco believe that they have the upper-hand in the international market a s 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 EnvironmentReputation with CustomersBy providing low prices for customers specially those living in the rural areas, many are grateful that they provoke save up. In addition, Wal-Mart has become so powerful that it is able to sell well- cognize brands at lower prices and thus proving the superior value it brings to its customers.CapabilitiesWal-Mart is equipped with first-hand in formation about consumer preference data by having suppliers to attach remote control frequency devices (RFID) engineering in all their packaging to track individual items sold in the store. To alter efficiency of all business trans marchs 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 CompetencyIn 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.Stakeh honest-to-goodnesss of Wal-MartSuppliersThe 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 spontaneous 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. S uppliers 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 sales pitch that they miss or delay.EmployeesEmployees 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 get practice against women in separate occasions.SWOT(S)trengthsHas its own logistics as well as its own trucks and a private satelliteA systematic and controlled management practice with the suppliersFirst-hand data about customer preference, more insight into the target market(W)eaknessesWal-Marts image problem where the supplier are intimidated by itIgnores price increase- resulted in the suppliers shutting down, be forced into a merger/ transfer the production overseasIndirectly linked to thousands losing their jobs(O)pportunitiesWal-Mart as a willing teacher, constantly educating t he suppliers with new proficiency to tackle cost control and efficiency more would be ready to work with it(T)hreatsUnreliable employees because of how they are treated by Wal-Mart young chains like Dollar General contesting Wal-Marts position in the US retail marketReview of Present SituationThough Wal-Mart is a powerful retailer in US and nearly 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.RecommendationsCreate a positive image of Wal-MartTo avoid being blamed for all the jobs broken 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 clement organisations as a way of showing that the retailer also ca res and gives back to the society. Wal-Mart could also create a fund to fear jobless people until they get another job.Gain employees loyaltyReferencesRamaswamy, 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 contract Here. BusinessWeek Online. Retrieved from http//www.businessweek.com/bwdaily/dnflash/sep2003/nf20030929_9676_db014.htmWhat Influenced Georgian Style and its Features?What Influenced Georgian Style and its Features?IntroductionGeorgian vogue is a call in the computer architecture, interior trope, and decorative arts of Britain during the 17th and eighteenth centuries. The term 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. Georgian is a term usually associated in the popular mind with refined furniture, elegant clothes, buildings of deceptive simplicity, stainless music, decorous prose, and awkward 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 classicismEach architect or designer has his own ideas and individual approach. However, all of them had someslenderg common they were severely 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 Gods creation and the acc ords of nature. Furthermore, this (Georgian) period is defined as an era of refined neoclassical trends. (Worldguide, 2015)As it was mentioned earlier, the Georgian style was exceedingly influenced by classicism. Young British aristocrats (including architects, designers and furniture makers) in the 17th and 18th centuries took the Grand Tour of European countries. These Grand Tours make 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 hardy and calm way. (Worldguide, 2015) If Baroque is too much, Georgian classicism is a grace.Early Georgian style Influence of PalladinismBesides classicism, there was another style that had a very strong impact on the Georgian style. It is a Palladinism, a philosophy of design based on the writings and work of Andreas Palladio. (David Ross, 2015) He is an Italian ar chitect 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 actorive role 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 romish temple facades and pillars. In addition, a mathematical formulae was used for a buildings proportion. However, after 1750 (Dan Cruickshank, 2011) or from around 1760 (Worldguide, 2015), English architects James Stuart, Sir William Chambers and frugal architect Robert ex were exposed to a pass oner style of classicism around Britain. They were inspired by the archaeological discoveries at Pompei and Herculanium. This new information about Hellenic and Roman architecture brought about a neoclassica l revolution in savour. 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 ExamplesJames StuartOne of the best examples of neoclassicism is James Stuart (1713-1788). He went on various 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 Athenian Stuart. In addition, he published Antiquities of capital of Greece in separate books from 1762. (Worldguide, 2015) On the picture below shows an example of his work(St Jamess Square, London)Sir William ChambersSir 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 exp lanation 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 AdamOne 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 ribbons, wreaths, sphinx and griffins, ovals and hexagons and so on. This style was famous as the Adam style. (Worldguide, 2015)(Syon House, West London)Late Georgian styleLate 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 a nd 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 beautify plaster than noticeable brick. Moreover, interiors were more open and light, and windowpanes became expectantr. In my personal opinion, the Regency style (Late Georgian style) is akin to a bridge between early Georgian design and approaching Victorian era.Henry HollandFor instance, Henry Holland (1745-1806) was the most leading architect of the late(a) Georgian period. (Worldguide, 2015) Hollands 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 styleLandscapeThere are many characteristics defining the Georgian p eriod. 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 sizings 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 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 country houses. (David Ross, 2015) These estates were full of reproductions of classical temples and additional architectural pieces grottoes, bridges, and that theme of fragments called follies. Basically, these parks carried on the classical philosophy.ArchitectureFurthermore, 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 lusty is prominent (DesignIntuit, 2001), and shapes are classical. The foundation of Georgian proportion was usually geometrical, with the central block of the building often augmented by hyphens and wings (Wentworthstudio, 2015) Homes were only symmetrical. There was not usually an even number of windo ws (five across for house). This did not allow asymmetry around the middle window of the building.Sash windows 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 plunge 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 artsIn the Georgian period, there was a significant rise in popul arity 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. closeSadly, that period could not last. Victorian m oral examinationity 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 u rban living.BibliographyGeorgian Style, David Ross, 2015 (http//www.britainexpress.com/architecture/georgian.htm)The Georgian Style of British Colonial Annapolis, DesignIntuit, 2001 (http//www.designintuit.com/issue0002/focus/ghistory.html)The Georgian Era of Great Britain, Worldguide, 2015 (http//www.worldguide.eu/wg/index.php?StoryID=148ArticleID=21368)Georgian architecture a classical re-education, Dan Cruickshank, 2011 (http//www.theguardian.com/artanddesign/2011/sep/11/georgian-architecture-british)Historic styles Georgian style, Wentworthstudio, 2015 (http//www.wentworthstudio.com/historic-styles/georgian/)Georgian architecture, Britannica, 2015 (http//www.britannica.com/EBchecked/topic/230322/Georgian-style)1Fast Dissolving Drug oral communication Systems A Brief OverviewFast Dissolving Drug Delivery Systems A Brief Overview1.1 Introduction to fast profligacy process delivery systemFast licentiousness drug delivery systems have rapidly gained sufferance 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, lip dissolve dosage forms or melt-in- sing 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 in alive(p) ingredients. Most of the drug is swallowed with the saliva where subsequent submerging takes place in the gastrointestinal tract. By definit ion, 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 SystemEase of administration for patients who are mentally ill, disabled and uncooperative.Requires no waterQuick anarchy and diarrhea of the dosage form.Overcomes unacceptable taste of the drugs.Can be designed to leave minimal or no balance wheel in the mouth after administration and also to provide a pleasant mouth feel.Allows high drug loading.Ability to provide advantages of liquid medicine in the form of solid education.Adaptable and amenable to existing processing and packaging machineryCost- effective 5-9.1.2 Characteristics of Fast Dissolving Delivery System 5 1.2.1 Ease of administrationFast Dissolving Delivery Systems are easy to administer and handle hence, leads to better patient compliance. Usually, elderly people experience difficult y in swallowing the customary dosage forms (tablets, capsules, solutions and reprieves) because of tremors of extremities and dysphasia. Fast Dissolving Delivery Systems may offer a solution for these problems.1.2.2 Taste of the medicamentAs most drugs are unpalatable, mouth dissolving delivery systems usually contain the medicament in taste clothed 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 HygroscopicitySeveral fast dissolving dosage forms are hygroscopic and cannot maintain physical integrity under normal condition from humidity which calls for specialized product packaging 10.1.2.4 Mouth feelMouth 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 unplea sant gritty feeling. This can be overcome by keeping the majority of the particles below the detectable size limit. In some cases, certain savours 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 hire.2.1 descriptionThin 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 level. Thin film drug delivery has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with prescription and OTC medications. connatural in size, shape and thickness to a postage stamp, thin film deprives are typically designed for oral administration, with the user placing the strip on or under the vernacular or along the inside of the cheek. As the strip dissolves, the drug can enter the blood rate of point enterically, ducally or sublingually.The first mercenary 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 filmThe 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 inhalants14.The sublingual and buccal delivery of a drug via thin film has the potence to improve the onset of action, lower th e dosing, and conjure up the efficacy and safety profile of the medicament.All tablet dosage forms, softgels and liquid expressions 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 truth relative to liquid formulations since every strip is manufactured to contain a precise amount of the drug.Thin film not only ensures more right 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 especia lly 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 pitiful 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 gallop revenue lifecycles for pharmaceutical companies whose drug patent is expiring and will soon be vulnerable to generic competition.Advantages of Oral Thin FilmThin elegant filmConvenient dosingFast disintegrationEnhance stabilityQuick dissolvingImprove patient complianceRapid fallLife cycle managementmucoadhesionTaste maskingunobstructiveNo risk of chokingVarious sizes and shapesNo water needed2 .3 Need for fast dissolving thin film drug development2.3.1 Taste maskingAn important aspect of thin film drug delivery technology is the masking of the often bitter and poor taste of drug formulations14.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 throwd 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-Cycl odextrin by simple kneading method.2.3.2 Drug content uniformityDrug content uniformity is a requirement for all dosage forms, particularly those containing low dose passing potent drugs. To uniquely meet this requirement, thin film formulations contain uniform dispersions of drug throughout the whole manufacturing process15.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 process16.2.3.3 Avoiding drug degradationSensitive drugs may degrade over time in an sedimentary 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 passing specialized unique and often proprietary processes to deliver drugs on thin film 18.2.4 Functionality of oral thin filmPharmaceutical 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 genus Apis. The formulation of dissolvable films is customarily facilitated through aqueous polymer matrices that span a wide molecular cargo (MW) range, thereby providing flexibility to achieve certain physical properties. With the selection of appropriate polymer excipients, these properties can be tailored to meet peculiar(prenominal) API-loading needs and dissolution rates.To date, the commercial launch of OTFs is primarily in OTC products addressing cure categories such as cough/cold, sore throat, and antacid/gas second-stringer as well as a number of nutritional supplement ap plications 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 wrapped more rapidly through the oral mucosal and esophageal tissues via OTF formats during ingestion. Because the drug ent ers 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 nauseated system disorders.Functional film properties controlled during manufacturing burdensomenessWidthDrug concentrationresidual volatilestensile strnthdisintegration ratesdissolution rates2.5 oral thin film as Strategic therapeutic categoriesOTF 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 sens 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 filmsContraceptionHormone replacementPain managementAllergy and asthamaNauseaCentral nervous system disordersAnti-inflammatoryGastro-intestinalSleep aidsVeterinary medicines and vitamins3. Drugs availability in market as a film/stripThe use of thin-film strips is of growing post in the pharmaceutical sector following the success of Listerine PocketPaks in the Unite d 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 trendsTCIs report also details the technology programs of 25 companies active in the development of Orally-Disintegrating yellow journalism technologies and 17 active in the development of Oral Film technologies. Technology Catalysts fore heaves the market for drug products in oral thin film formulations to be determine 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 utter 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 fluent Nose, in grape flavour. They will cost approximately $5.99 for a 16-strip pack, according to Novartis.5. Formulation consideration5.1. film forming polymerA variety of polymers ar e available for preparation of OS. The polymers can be used alone or in crew 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 tip 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 chemic al 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 forcing out 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 polymernon-toxicnon-irritantdevoid of leachable impuritiesgood wetting propertyspreadability property quickly availableShould not be very expensiveShould 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 bio self-sealing strips or patches that need to be retained in built-in 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 drawn-out 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 anaesthetic enzyme inhibition action along with penetration enhancing property. The details of properties of bioadhesive or mucoadhesive polymers and their applica tions are discussed elsewhere 36-43. Mucoadhesive polymers overwhelm polycarbophil, cellulose derivatives like hydroxy propyl radical radical methyl groupcellulose, 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.TablePolymer Hydoxy propyl methyl cellulose (HPMC)SynonymMethocel, Metolose,Benecel(Hypromellose)Description It is a odorless, tasteless and white or creamy white fibrous or granular powderMolecular weight 10,000-1,500,000solvabilitySoluble in cold water,forming a glutinous colloidalsolution, insoluble inchloroform, ethanolPolymerHydroxy propyl celluloseSynonymHydroxyl propyl ether,hyprolose, Klucel, Nisso HPC.DescriptionIt is a white to slightly yellowcolored, odorless andtasteless powder. It is stablematerialMolecular weight50,000-1,250,000 solubilityIt is freely soluble in waterbelow 38 C forming asmooth, clear, colloidalsolution. Hydroxypropylcellulose is soluble in manycold and hot polar organicsolvents such as absoluteethanol, methanol, isopropylalcohol and propylene glycolPolymerStar ch and modified starchSynonymAmido, amylum, PharmGel,Fluftex W, Instant pure-Cote,Melogel etc.DescriptionIt is an odorless, tasteless,fine, white powder.Molecular weight50,000-160,000SolubilityIt is insoluble in coldwater and ethanol. It swells inwater by about 5 to 10% at37 CPolymerPullulanSynonymPullulane, 1, 6 linkedmaltotrioseDescriptionIt is available as white,odorless tasteless, stablepowderMolecular weight8000-2,000,000SolubilityIt is soluble in hot as well ascold waterPolymerPectinSynonymCitrus pectin, Methopectin,pectin, pectinic acidDescriptionIt occurs as a yellowishwhite,odorless powder withmucilaginous taste.Molecular weight30,000-100,000SolubilityIt is soluble in water butinsoluble in most of theorganic solvents.PolymerGelatinSynonym Byco, cryogel, Instagel,SolugelDescriptionIt occurs as light amber tofaintly yellow colored,vitreous, brittle solid. It isordorless, tasteless.Molecular weight15,000-250,000SolubilitySoluble in glycerin, acid andalkali. Swells in water an dsoftens. It is soluble in hotwaterPolymerCarboxy methyl celluloseSynonym Akulell, Blanose, AquasorhDescriptionIt is white, odorless powderMolecular weight90,000-700,000Solubility It is easily dispersed in waterto form a clear or colloidalsolution5.2 PlasticizerPlasticizer 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 return 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, triaceti n 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 ingredientThe 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. mainly 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 performerSweeteners 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 substitute sweeteners are used to improve the palatability of the mouth dissolving formulations. Sweetening element 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, l iquid glucose and maltose. The corsage 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 conventionalized 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 jointure 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, maltodextrin was employed assweetening agent 67. Generally sweeteners are used in the concentration of 3 to 6 %w/w either alone or in combination 68.5.5 flavoring agentPerception 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 maskthe taste depends on the flavor type and its strength. quite 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 agentColoring agents may include FD C coloring agents, natural coloring agents, and natural juice concentrates, pigments such as titanium oxide, silicon dioxide and zinc ox ide. (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 agentThe 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 agentThe 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 ac id, 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. nourishment 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 filmOne (or a combination) of the following processes may be used to manufacture the oral films 74.Solvent casting hot-melt extrusionSolid dispersion extrusionRolling6.1 Solvent CastingThe 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 extrusionHot melt extrusion (HME) is commonly used to prepare granules, sustained-release tablets, transderm

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