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The wide diversity of structures and targets is featured in this chapter and the many discoveries have pushed research and drug discovery forward signifcantly purchase 200 mg cefpodoxime antibiotics for uti toddler. Hruby have taken on the task of describing methods to limit the metabolism of peptide molecules in humans purchase cefpodoxime without a prescription antibiotic resistance video clip. As Victor Hruby is the world leader in this aspect of peptides order 200 mg cefpodoxime with amex antibiotic vs anti infective, the chapter is thoroughly exciting and interesting. A main concern is the digestion of peptides by proteolytic enzymes present in both the digestive tract and the circulation. The frst step is to defne the pharmacophore residues of a naturally occurring and effective peptide. This will show the absolutely critical functional groups and their stereochemical relationships that must be maintained. Then replacement of some nonessential amino acids by non-natural amino acids, with the d-amino acid isomer, or with peptide-bond isosteres may be suffcient to block degradation by proteases. Other strategies include replacement of specifc the amino acids with the N-methyl derivatives, with topographically constrained derivatives, or with the halogenated derivatives of aromatic amino acids. Finally, the use of the “multiple-antigenic-peptide” approach where many molecules are attached to a carrier with multiple attachment points can produce molecules that, due to their size, are not recognized by proteases. This chapter emphasizes the role of creative synthetic chemistry is the modifcation of peptides to achieve stability and bioavailability. The book concludes with Chapter 8, provided by Jeffrey-Tri Nguyen Yoshiaki Kiso, that discusses the important area of peptide delivery. While progress in the past 50 years has permitted peptide chemists to make almost any sequence of amino acids that is desired in high yield and purity, getting those molecules into humans and into the specifc area in the body where they can exert a therapeutic effect is a problem that has not progressed as rapidly. Thus, this chapter is very important for future advances in drug discovery based on peptides. Many of the readers may already be familiar with the Lipinski’s Rule of Five that includes recommendations for the size of a molecule, the number of hydrogen bonding atoms, and the lipophilicity. These rules are discussed in this chapter, but much more information is provided regarding solubility, membrane transport, and metabolic stability. In conclusion, this book provides a primer for anyone in the feld of drug discovery and specifcally in the area of the use of peptides as molecules for both the discovery phase and, in favorable cases, the fnal phase of the creation of new molecular entities that can be moved into further studies to evaluate their potential as therapeutic drugs. I want to thank the authors of the chapters for their friendship, for many discussions, and for their excellent writing for this book. Craik, Institute for Molecular Bioscience, The University of Queens- land, Brisbane, Queensland, Australia Ayman El-Faham, Department of Chemistry, Alexandria University, Alexandria, Egypt; Department of Chemistry, King Saud University, Riyadh, Kingdom of Saudi Arabia Gregg B. During that period a number of great peptide drugs such as Sandostatin, Lupron, Copaxone, and Zoladex were developed with great therapeutic beneft. It was not until the last decade that we have seen a signifcant surge in the number of peptide therapeutics on the market (Figure 1. While 10 peptides were approved between 2001 and 2010, the current decade has thus far witnessed the approval of six new peptide therapeutics – a remarkable yearly increase [1, 2]. The number of peptides in development is also steadily growing roughly doubling every decade (Figures 1. This is due to the advances made in our understanding of peptide stability, peptide syn- thesis, and formulation over the last three decades. Although the market share of peptide drugs is still relatively small (about 2% of the global market for all drugs), the approval rate for peptide drugs is twice as fast as the rate for small molecules, and the market is growing similarly at a rate that is twice the global drug market [3, 4]. With the exception of a few peptides, the approved drugs so far tar- get the extracellular compartment, and thus have to compete with biologics. We have seen a great advance in extending the circulating half-life of the peptides through the use of unnatural amino acids and formulation technologies, but have not yet reached the half-life achieved by antibodies. To dramatically heighten their impact, peptides need to access the intracellular space to target protein–protein interactions. These interactions represent a vast source of potential targets with signifcant biological impact (there are estimated 300,000 such interactions in the cell), and will not in the majority of cases be modulated by small molecules. Peptides and biologics, given their relative size and ability to bind to extended surface areas, are the perfect candidates to inhibit protein–protein interac- tions. The duration of action of peptides needs to be extended, and while peptides are inherently selective against their targets, they need to more selectively distribute to the desired tissue. Finally, the route of administration needs to be expanded to include oral delivery. Many of the techno- logical advances are already proving that it is possible to make peptides permeable to cells, target tissues, have longer half-lives, and be orally bioavailable. The discovery that certain peptides can penetrate cells and can, therefore, be an effective therapeutic on their own or alternatively bring other drugs into cells allowed for the frst time to imagine targeting the intracellular compartment (Figures 1. It is hard to compete with the screening of the mil- lions of small molecule compounds in various pharmaceutical companies and more recently in many academic centers. Indeed, over the last decade, there has been an explosion of very elegant tech- nologies that now allow the generation of large to extremely large libraries of linear and macrocyclic peptides with unnatural amino acids and unnatural linkers. For the frst time, it is possible to engineer stability, cell permeability, and possibly oral bioavailability at once and screen for the desired properties very rapidly. These major advancements have resulted in the generation of a number of companies that are pushing the limits of these technologies to rapidly screen and identify novel peptide therapeutics against protein–protein interaction targets (Figure 1. Through medicinal chemistry optimization, they have now identifed picomolar inhibitors with good properties . These peptides contain a com- bination of natural, unnatural, and N-methyl amino acids and exhibit good physico- chemical properties and membrane permeability . They recently presented on their discovery of potent antagonists of mcl-1 and Ras with good cell permeability . David Craik and colleagues at Cyclotide are systematically exchanging the various loops present on cyclotides with sequences that have important biological function . Moreover, novel technologies developed for the rapid generation and screening of extremely large libraries of knottins and cyclotides will undoubtedly have a major impact on this class of peptide therapeutics. Of note is the Intein-based technology from Julio Camarero capable of introducing unnatural amino acids to facilitate screening . Sutro and MitiBio also have very sophisticated and effcient biosynthetic methods to generate very large libraries. Finally, Verdine and Wollensky and colleagues [22, 23] as well as the investiga- tors at Aileron Therapeutics have developed a novel stapling technology that imparts stability and membrane permeability to alpha helical structure. This is due to the fact that once the peptide enters the cell, the major elimination pathway is through enzymatic catabolism. Not only can stability be tuned for circulating half-life, it can also be tuned to withstand cellular catabolism to lengthen the desired effcacy. This could offer a signifcant advantage over (small) molecules that passively diffuse through the cell membrane. Main reasons for diminished safety are selectivity against the target and tissue/cell specifcity. If one could direct a therapeutic to only the site of pathology, then the therapeutic window of the agent increases and correspondingly decreases the side effects.
The chip holds the product’s unique serial number 100mg cefpodoxime overnight delivery antibiotics for dogs at petco, expiry date cefpodoxime 100 mg overnight delivery infection rates in hospitals, batch code generic 100mg cefpodoxime otc antibiotic pseudomonas, and information about its previous transactions; the antenna, when activated by the tag reader, conducts radio energy to the chip to send and receive data (Lefebvre et al. The technician reading the chip does not need to position the reader within sight of the tag to read it; the signal is sent by radio waves, not sight. The amount of information encoded in electronic product codes and the ease of accessing this information make the system attractive for drug pedigrees (Lefebvre et al. The technology clearly has innovative potential, but a critical mass of intermediaries on the drug distribution chain need to upgrade their systems for it to be useful (Lefebvre et al. Consumer electronics and other expensive products are commonly labeled with radio frequency tags, but using the technology for medicines presents obstacles. After marking each primary package (the smallest unit of packaging) with a radio frequency tag, access to the electronic product code database neces- sary to decipher the information in the chip costs about $50,000 in the frst year (Wunder and Roach, 2008). Generics companies in many parts of the world share this sentiment, although the generics industry is not at consensus on the question (Barlas, 2005; Jagdale, 2010; Wolinsky, 2006). Even if the technology were cheaper, it is unclear that it would be practical in the markets most hurt by falsi- fed drugs. Chapter 3 explains that the burden of falsifed medicines is borne mostly by the poor, especially the poor in low- and middle-income countries, who buy drugs at unlicensed drug stores and unregulated street markets. Mobile phone verifcation, an ingenious form of mass serialization, can fll in for an electronic pedigree at a drug’s last step to the consumer. Mobile verifcation companies such as Sproxil take subscriptions from drug companies and wholesalers. Sproxil provides labels to their clients; each label is marked with a visible serial number and secret code hidden under the scratch-off surface. When the label is attached to the fnal package, the manufacturer enters the visible serial number in the Sproxil database through a secure web portal. The visible serial number links the product manufacturer, batch number, manufacture, and expiry dates to the secret scratch-off code. At the point of purchase, the consumer sends a text message or, in some systems, an e-mail to the verifcation company, the company that makes the scratch-off labels and manages the linked database. An immediate text message response confrms if the secret code number is registered with the manufacturer, or if it is from a shipment reported to have left the legitimate supply chain. Mobile verifcation of pharmaceuticals is gaining users in 17 sub-Saharan African countries and India (Mukherjee, 2012; Sproxil, 2012; Versel, 2012). An elegant system for assigning unique product numbers, mobile verifcation empowers consumers to act for their own safety. Mobile verifcation cannot prevent fraud, nor is it a substitute for phar- macovigilance and postmarket surveillance. A product could be substan- dard at the factory but still gain a valid mobile verifcation label. Mobile verifcation, however, appeals to good-quality manufacturers, who see the service as an investment in their brand or as a way for consumers to have Sproxil standard labels with visible serial number and scratch-of covering the secret code number. A more likely problem would be a wholesaler assigning a legitimate label to a falsifed drug. Also, the verifcation service only confrms a product’s identity at the end of the distribution chain, at purchase. These systems cannot track the chain of custody or monitor if the product has been stored and transported properly. A reliable system for tracking and tracing drugs through the distribu- tion chain would greatly reduce the likelihood of falsifed and substandard medicines reaching patients. Recent technological advances, such as the use of radio frequency identifcation and the expansion of mobile phones in de- veloping countries, hold promise for supply chain security. The committee believes that manufacturers and governments should use these technologies to integrate all records of a drug’s chain of custody. A mandatory track-and-trace system for drugs is the best way to moni- tor the chain of custody and protect patients from unsafe drugs. A full track-and-trace system would allow all parties in the drug distribution chain to see a complete record of the product’s path from the manufacturer to the patient (Rappeport and Jack, 2012). Track-and-trace systems place unique demands on drug manufacturers, retailers, and wholesalers. Some may see the imposition of a drug pedigree system as a matter of pharmacy practice, and therefore under the jurisdiction of state boards of pharmacy, the state health department, or another state authority. This authority should accompany an increase in funding to allow the agency, which has received many unfunded mandates in recent years, the staffng and technical upgrades necessary to monitor compliance (McCain, 2011; Palmer, 2010). A track-and-trace system would allow pharmacists to identify suspi- cious drugs before dispensing them and would facilitate more effcient product recalls (Buynak, 2011; DeCardenas, 2007). Companies tag drug pallets or other bulk packages with radio frequency tags, for example, but use barcodes or other identifers on smaller units (Lefebvre et al. Nevertheless, consumers and governments have demanded a stronger chain of custody (DeCardenas, 2007). This problem has been lingering for years and should be addressed promptly (Palmer, 2012). Without a clear federal mandate on the problem, companies and state governments work in a state of uncertainty, not knowing where and how to make the neces- sary investments that track-and-trace will require. If Congress does not set a mandatory requirement, then the competing demands of state track- and-trace systems will create an unmanageable burden for manufacturers, wholesalers, and retailers. Stakeholder comments on the workshop mentioned the importance of track-and-trace and “the need for one standard, without variations imposed, for example, by individual states” (Ducca, 2011). Any track-and-trace system will be an expense to manufacturers and industry, but the expense can be contained by making one national requirement. An increased track-and-trace requirement will put a fnancial burden on these companies, even if the added cost is low. This can help control the burden an inevitable shift to drug tracking will put on these businesses. Tracking primary packages through the drug distribution chain with unique serial numbers is a good defense against criminal infltration (Ludwig, 2012; Pellek, 2009; Power, 2008). A method of tracking medi- cines from the factory to the consumer could greatly reduce the chances of a dangerous product being sold at a reputable pharmacy. These solutions are of limited value in the vast pharmaceutical gray markets, however. Ig- norance, convenience, and desperation, or some combination thereof, drive patients to unlicensed pharmacies in street bazaars and on the internet. Medicines retail, the last leg of the drug distribution system, is often the most chaotic. The risk increases as drugs move farther from the manufacturer en route to the vendor. Licensed pharmacies and dispensaries can control the quality of their stock, at least insomuch as they can trust their wholesalers.
Making falsifed medicines is driven by the interests of criminals cefpodoxime 100mg line antibiotics for sinus infection while breastfeeding, who weigh the millions of dollars in potential profts against low odds of getting caught generic cefpodoxime 100mg on line antibiotic prescribing guidelines. These products circulate because national regulatory authorities are often poorly equipped to detect problems and act against them cheap cefpodoxime 100mg fast delivery antibiotic xerostomia. Sentences Country Dollars) Up to 6 months Indonesia a Up to $30 Up to 2 years Tanzania b Up to $57,000 Up to 3 years Japan, c Malaysia d Up to $40,000 Canada e Up to $5,000 Lebanon f Up to $30,000 Singapore g Up to $100,000 Up to 5 years Jordan h Up to $15,000 France, i South Africa, j $100,000 or more Switzerland k,l Up to 10 years Colombia, m Germany,n Monetary penalty not disclosed Peru o Uganda p Up to $2,000 Pakistan q Up to $5,000 Argentina, Cambodiar s Up to $15,000 South Korea, Taiwant u $100,000 or more * Additional penalties and fnes may be associated with specifc infractions. Fight against counterfeit medical products: The Medicrime Convention and the Swiss experience. Presentation given at International Conference of Drug Regulatory Authorities, Singapore. Sentences Country Dollars) Up to 15 years Nigeria v Up to $5,000 Brazil w, x Up to $98,000 Kenya y Up to 5x the value of the medicine Up to 20 years Grenada, z Mexico aa $100,000 or more Up to life China bb, cc Up to 5x the value of the medicine imprisonment or death India dd Up to $20,000 or 3x the value of the medicine Philippines,ee United States f $100,000 or more Thailand gg Up to $1,700 m Bate, R. China broadens scope of counterfeit drugs criminal prosecution, but defnition still murky. Dollars) No imprisonment Grenada,a India,b Damages are recovered for infraction Malaysia,c Pakistan, d Philippines, e South Africa,f Uganda, g United States h Taiwan i Infringer must may patentee profts earned Jordan, j Nigeria k Patentee may fle a civil or criminal lawsuit China, Perul m $100,000 or more Mexico n $80,000 or more Up to 1 year Brazil o Monetary penalty not disclosed Canada p Up to $500 Singapore q Up to $10,000 Switzerland r $100,000 or more * Additional penalties and fnes may be associated with specifc infractions. Dollars) Up to 2 years Thailand s Up to $13,150 Up to 3 years Germany t Monetary penalty not disclosed Lebanon u Up to $33,000 Up to 4 years Indonesia v Up to $50,000 Up to 5 years Cambodia w Up to $5,000 France x Up to $650,000 Japan y Up to $100,000 with labor Kenya z Up to $6,000 Tanzania aa Up to $300 5 or more years Argentina bb, cc Monetary penalty not disclosed South Korea dd Up to $100,000 with labor q Singapore Patents Act as amended by Act No. Sentences Country Dollars) No imprisonment Cambodia, a Germany,b Damages are recovered for infraction India,c Pakistan,d Philippines, e Singapore, f South Africa, g Uganda,h United States, i Korea j Up to $47,000 China, k Taiwan l Infringer must pay the trademark owner profts earned from the infringement or the amount of losses that the trademark owner has sufered Jordan m Up to $8,500 Up to 3 days Mexico n Up to $70,000 Up to 1 year Switzerland o Up to $110,000 Brazil p Monetary penalty not disclosed Up to 2 years Argentina q Up to $30,000,000 Up to 3 years Lebanon r Up to $0. Paper presented at 10th Phar- macovigilance Training Course held at Uppsala Monitoring Centre, Uppsala, Sweden, May 25. Address by the director general of the National Agency for Food and Drug Administration and Control, Dora Nkem Akunyili. Counterfeit drug demand: Percep- tions of policy makers and community pharmacists in Sudan. Local pharmaceutical production in developing countries: How economic protectionism undermines access to quality medicines. Pilot study comparing technolo- gies to test for substandard drugs in feld settings. Crime oppotunities provided by legislation in market sectors: Mobile phones, waste disposal, banking, pharmaceuticals. Country specifc case studies—best practices to combat counterfeit medi- cines and to protect public health. Health professionals in the risk communication process on counterfeit medi- cines. Workshop on Tracing Pharmaceuticals in South Asia, University of Endinburgh, Centre for International Public Health Policy. Exploratory study on active pharmaceutical ingredient manufacturing for essential medicines. Compounding pharmacies have long evaded the tight oversight governing established drug makers. Medicines prices, availability, and affordability in 36 developing and middle-income countries: A secondary analysis. Sub- standard medicines in resource-poor settings: A problem that can no longer be ignored. Exophiala infection from contami- nated injectable steroids prepared by a compounding pharmacy. Qual- ity medicines for the poor: Experience of the Delhi programme on rational use of drugs. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in northern Nige- ria. Paper pre- sented at Workshop in International Public Affairs, La Follette School of Public Affaris, University of Wisconsin–Madison, May 21. A survey exploring knowl- edge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia. The global threat of counterfeit drugs: Why industry and governments must communicate the dan- gers. Press release: Belgian citizen sentenced for selling counterfeit, misbranded drugs. Fake antimalarials in Southeast Asia are a major impediment to malaria control: Multinational cross-sectional survey on the prevalence of fake antimalarials. Guidelines for the award of procurement contracts within the framework of humanitarian aid actions fnanced by the European Union. Counterfeit medicines: Filled with empty promises (print public service announcement). Department of Health and Human Services, Food and Drug Administration, inspection form for New England Compounding Pharmacy, Inc. What can consumer adverse drug reaction reporting add to existing health professional-based systems? Ensuring drug quality in global health programs: Briefng for congressional requesters. Pharmaceuticals— East Africa: Establishment of a bioequivalence centre for East Africa in Addis Ababa. Guide to the Global Fund policies on procurement and supply manage- ment of health products. Guide to the Global Fund policies on procurement and supply management of health products. Generic substitutions: A 2005 survey of the acceptance and per- ceptions of physicians in Jamaica. Report of the Expert Committee on a Comprehensive Examina- tion of Drug Regulatory Issues, Including the Problem of Spurious Drugs. Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (over the counter) in Surabaya, Indonesia. Emerging challenges and opportunities in drug registration and regulation in developing countries. London: Health Systems Resource Centre, Depart- ment for International Development. The drugs stop here: A public health framework to address the drug shortage crisis. The business of health in Africa: Partnering with the private sector to improve people’s lives. Yvonne Chaka Chaka performs “Proud to Be” at Interpol General As- sembly in Vietnam. Ensuring safe foods and medical products through stronger regulatory systems abroad. Local production of pharmaceuticals: Industrial policy and access to medicines—an overview of key concepts, issues and opportunities for future research. Policies to promote use of generic medicines in low and middle income countries: A review of published literature, 2000- 2010. Vaccine supply chains need to be better funded and strengthened, or lives will be at risk. Testimony on protecting the nation’s health and safety before the House Committee on Commerce, Subcommittee on Health and Environment.
While mixing and under vacuum purchase genuine cefpodoxime online antibiotics for acne not working, allow the monostearate discount cefpodoxime 100mg visa antibiotic gastroenteritis, and white beeswax and mix mixture to cool gradually to room tempera- continuously while heating to 71°–75°C cheap 100mg cefpodoxime visa antibiotics for uti in 3 year old. Fluocinonide Cream, Ointment, and Gel The active component is the corticosteroid ﬂuocinonide, (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, which is the 21-acetate ester of ﬂuocinolone acetonide. This white cream vehicle is disodium, propyl gallate, propylene glycol, sodium hydrox- greaseless, nonstaining, anhydrous, and completely water ide or hydrochloric acid (to adjust the pH), and water (puri- miscible. In this formulation, the active ingredient is totally nonstaining, and completely water miscible. It provides the occlusive Another strength of cream contains ﬂuocinolone and emollient effects desirable in an ointment. In of butylated hydroxytoluene, cetyl alcohol, citric acid, another formulation, the ointment contains ﬂuocinolone edetate disodium, methylparaben and propylparaben acetonide 0. The mixture is heated until about 70°–80°C, and then a 2% aqueous solution of triethanola- 1. The mixture is stirred well and then cooled to solution of carboxyvinyl polymer (20 g), puriﬁed give a creamy preparation having a viscosity of water (47 g), and a 1% aqueous solution of 65,000 centipoises and a pH of 4. Inactives ical name is ﬂuorometholone [9-Fluoro-11(beta),17-dihy- are white petrolatum, mineral oil, and petrolatum and droxy-6(alpha)-methylpregna-1,4-diene-3,20-dione]. Formulations of Semisolid Drugs 159 Flurandrenolide Topical Film Bill of Materials Scale (g/100 g) Item Material Name Quantity/kg (g) 0. Add and dissolve ﬂurandrenolide in propylene including water over a period of 20–30 minutes, glycol, glycerine, and ethyl alcohol. Fluticasone Propionate Ointment Bill of Materials Scale (mg/g) Item Material Name Quantity/kg (g) 0. Transfer the drug mixture from step 3 into the manufacturing vessel from step 2 while mixing. Melt microcrystalline wax, hard parafﬁn, and Mix and homogenize for 10 minutes under vac- sorbitan sesquioleate in a fat-melting vessel at uum at 0. Cool to a temperature of 25°–30°C with con- turing vessel through stainless steel ﬁlter. Disperse ﬂuticasone propionate in propylene glycol, mix, and homogenize at a temperature of 40°–45°C. Each gram of ointment contains ﬂuti- 11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1, casone propionate 0. The topical corticosteroids constitute a class of pri- Fluticasone Propionate Cream Fluticasone propionate cream 0. Each gram of cream con- diﬂuoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopro- tains ﬂuticasone propionate 0. Fluticasone Propionate Cream Bill of Materials Scale (mg/g) Item Material Name Quantity/kg (g) 0. Transfer the drug mixture of step 5 into step 4 1000 in a fat-melting vessel at 70°C. Add puriﬁed water to the manufacturing vessel cream to contain labeled amount of drug per and heat to 70°–80°C. Transfer the fat phase of step 1 through a stain- with product identiﬁcation label. Formulations of Semisolid Drugs 161 Foscarnet Cream Bill of Materials Scale (mg/100 g) Item Material Name Quantity/kg (mg) 3. Melt items 2, 3, and 5 at 70°C in a small con- step 2 to the step 3 while stirring. Transfer the ointment to stainless steel drum ﬁlter to mixer and cool it down to 50°C. Formulations of Semisolid Drugs 163 Gentamicin Sulfate Cream Bill of Materials Scale (g/100 g) Item Material Name Quantity/kg (g) 0. Quantity of gentamicin sulfate per batch will vary according to the actual potency. While homogenization is in progress, set the steel ﬁlter while mixing at speed 10 rpm, vac- temperature at 25°C so that the cream temper- uum 0. Stop the homogenizer, set the mixer at temper- cream in stainless steel container and ﬁll. Gentamicin Sulfate Ointment Gentamicin sulfate ointment is a sterile, topical anti-infective (equivalent to 3. Gentamicin sulfate is the sulfate salt of gentamicin tamicin sulfate equivalent to 0. Immediately The suppository mass is manufactured at a temperature of transfer the hot mass to the heated storage ves- 120°C. Care must be taken to see that molten suppository sel or heated vessel of suppository ﬁlling mass does not accidentally spill on the person. Glycerin Suppositories Bill of Materials Scale (mg/suppository) Item Material Name Quantity/1000 Suppositories (g) 900. Formulations of Semisolid Drugs 165 Glycolic Acid Cream Bill of Materials Scale (g/100 g) Item Material Name Quantity/kg (g) 3. Gramicidin, Neomycin, Nystatin, and Triamcinolone Ointment Bill of Materials Scale (g/100 g) Item Material Name Quantity/kg (g) 0. Rinse homogenizer with liquid parafﬁn and add heat to 70°C to melt; transfer to Becomix rinsings. Mix till ointment is smooth, transfer to a stain- twice with ﬁne-gap setting to make smooth dis- less steel vessel, and ﬁll. Charge items 1, 2 (balance quantity), 3, and 6 in a separate stainless steel vessel and homogenize 166 Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products Halobetasol Propionate Cream and Ointment The cream contains halobetasol propionate, a synthetic halobetasol propionate in a cream base of cetyl alcohol, corticosteroid for topical dermatological use. The corti- glycerin, isopropyl isostearate, isopropyl palmitate, ste- costeroids constitute a class of primarily synthetic steroids areth-21, diazolidinyl urea, methylchloroisothiazolinone, used topically as an anti-inﬂammatory and antipruritic methylisothiazolinone, and water. Heparin Gel-Cream Bill of Materials Scale (g/100 g) Item Material Name Quantity/kg (g) 0. Formulations of Semisolid Drugs 167 Hexachlorophen Cream Bill of Materials Scale (mg/g) Item Material Name Quantity/kg (g) 45. While both solutions are at 65°–70°C, form the primary emulsion by pumping the aqueous solu- 1. Strain olive oil through voile cloth or equivalent tion from step 5 into the oil mixture from step 3 into a suitable stainless steel-jacketed tank. Homogenize primary emulsion through a Troy ate mix, add cetyl alcohol, lanolin, petrolatum, Mill, or similar device, into the balance of aque- and polysorbate 40 with mixing. Add and dissolve hexachlorophene in the oil emulsion should strained through voile cloth or mix, then add and disperse the simethicone. Cool emulsion to 40°–50°C with agitation glycerin, methylparaben, and borax as puriﬁed under vacuum. Reserve 4 mL of solution from step 5 in a separate container to rinse equipment in step 2.