Tablets & Capsules

TC0917

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Tablets & Capsules September 2017 43 thought to be one of the fastest growing segments in the pharmaceutical industry. The global HPAPI market is expected to reach $25.86 billion by 2022, with oncology therapies the primary driver [21]. Semi-solid formulations are mixtures that take the form of liquids during filling, then solidify in the hard capsule to form a non-porous crystalline plug, or solid dispersion. These formulations can be used to improve not only the dissolution of APIs with low aqueous solu- bility but also to sustain the release from relatively simple formulations. T&C References 1. Ng R. Drugs: From discovery to approval, 2nd Ed. Wiley-Blackwell. 2009. 2. Custodio JM et al. Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev 2008. 60(6): 717-733. 3. Timko R. Improving the bioavailability of APIs for delivery in oral dosage form. Tablets & Capsules 2016 14(5): 29-32. 4. Anilkumar. Solubility enhancement of BCS Class 2 drug by novel drug solution drop technique. May 2015. Pharmachitchat.com. Accessed August 11, 2017. 5. Browne J. Improving the odds of success during early development using lipid-based systems. February 2017. Seminar presentation, San Mateo, CA. 6. Holm R. Lipid suspensions—An approach to increase oral bioavailability or just greasy business? March 2017. DDF Summit, Berlin, Germany. 7. Mueller EA et al. Influence of a fat-rich meal on the pharmacokinetics of a new oral formulation of cyclosporine in a crossover comparison with the market formulation. Pharm Res 1994 11(1): 151-155. 8. Fatouros DG et al. Clinical studies with oral lipid based formulations of poorly soluble compounds. Ther Clin Risk Manag 2007 3(4):591-604. 9. Solaiman A et al. Mechanical properties of capsules shells made of HPMC. April 2008. Poster at 6th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology, Barcelona, Spain. 10. Bhat J et al. How to assess and prevent brittleness of hard gelatin capsules. Tablets & Capsules 2017 15(1):15-19. 11. Ware E. et al. Investigation of various lipid vehicles in two piece HPMC capsules. October 2011. Poster at AAPS Annual Meeting and Exposition, Washington, DC. 12. Podczeck F and Jones B (eds). Pharmaceutical Capsules. Pharmaceutical Press. 2014. 13. ACG product development department. Liquid filling and band sealing. Not published. 14. Biyani M. Filling of liquid, semisolids and hot- melts into capsules. Not published. 15. Hauss D (ed). Oral lipid based formulations: Enhancing the bioavailability of poorly water-soluble drugs. Informa Healthcare. 2007. 16. Lightfoot D. An overview of capsule sealing equip- ment. Tablets & Capsules 2013 11(1):10-16. 17. Evaluation of the use of AZD6244 to induce increased ER expression and anti-estrogen response in ER-negative/low breast cancer. clinicaltrials.gov. Accessed August 11, 2017. 18. Oramed granted European patent for combination oral insulin and GLP-1 analog capsule. Oramed Press Release. April 2017. 19. Melmed S et al. Safety and efficacy of oral octreotide in acromegaly: Results of a multicenter phase III trial. J. Clin Endocrinol Metab 2015 100(4): 1699-1708. 20. Bernkop-Schnürch A. The mucus gel barrier: Industrial applicable strategies to overcome it. March 2017. DDF Summit, Berlin, Germany. 21. Siew A. Liquid encapsulation for HPAPIs. Pharm Tech 2016 40(1):40-41. Jnanadeva Bhat, PhD, is general manager of formulations development, capsules; Fernando Diez is scientific business development manager, capsules; and Justin Kalafat is business development manager, capsules, in North America at ACG. The company operates worldwide. ACG North America is located at 229 Durham Avenue, South Plainfield, NJ 07080. Tel. 908 757 3425. Website: www.acg-northamerica.com. e xperts alik s and e beginner ͕ ŵ Ă Ğ ƚ Ő Ŷ ŝ ƌ Ƶ ƚ Đ Ă Ĩ Ƶ Ŷ Ă ŵ Ğ ƌ Ɵ Ŷ Ğ Ğ Ś ƚ ƌ Ž & -learning E sule Cap & t able Table erful w o P T Individuals or groups can select on-line training topics and training topics and ƌĞĐĞŝǀĞĂĐĞƌƟĮĐĂƚĞ ŽĨĐŽŵƉůĞƟŽŶ ƚĞĐŚĐĞƵƟ ƟĐĂůƐ͘ĐŽŵ

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