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Impact of Capsules as a Carrier for Multiple Unit Drug Delivery and the Importance of HPMC Capsules


Affiliations
1 Dept of Pharmaceutics, Bhaskar Pharmacy College, Yenkapally (V), Moinabad (M), R.R. District, Hyderabad-500075, India
2 Dept of Pharmaceutics, Jyothismathi Institute of Pharmaceutical Sciences, Thimmapur, LMD Colony, Karimnagar-505481, Andhra Pradesh,, India
     

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The word 'capsule' is derived from the latin capsula, meaning a small box. It is a solid oral dosage form in which the active ingredients and diluents are contained in a two-piece hard shell, usually made of gelatin. In the development of new medicines, there are several problems to be solved. The formulation, and its important stability and releasecharacteristics, control and reproducibility of the production process are other factors to be taken into account and, increasingly, research costs and development timeframes have also to be considered. When it comes to a decision at the end of phase II, which dosage form will be developed for the market, high production costs of hard gelatin capsule products are generally assumed. Multiple unit dosage forms are mainly oral dosage forms consisting of a multiplicity of small discrete units, each exhibiting some desired characteristics. It is even possible to include a number of dosage forms - such as tablets, pellets, capsules, powders and granules - within a single formulation. In this way, incompatibilities and interaction between the different drug substances in combination products can be prevented. Hard gelatin capsules are particularly suitable for their development and manufacture. Hard gelatin capsules do have some drawbacks. To overcome these problems, pharmaceutical scientists have developed capsules made of starch, cellulose derivatives and polyvinyl alcohol copolymer. To date, HPMC capsules have been successfully utilized for pharmaceutical products.

Keywords

Capsule, Solid Oral Dosage Form, Multiple Unit Dosage Form, HPMC
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  • Michael Aulton E. Aultons Pharmaceutics: The design and manufacture of medicines. 3rd edn 2007.
  • La Wall CH., 4000 years of pharmacy, an outline history of pharmacy and the allied sciences, J. B. Lippincott Comp., Philadelphia/London/Montreal 1940.
  • Sven Stegemann, Capsugel Bornem. Hard gelatin capsules today and tomorrow. Capsugel Library 2002; 2nd Edn.
  • Sastry SV, Nyshdham JR, Fix JA. Recent technological advances in oral drug delivery: A review. Pharm Sci and Tech Today 2000; 3:138-45.
  • Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J. of Pharma and Pharmaco 1998; 50(4): 375-82.
  • Leon Lachman, Herbert Lieberman A. The theory and practice of industrial pharmacy. Special Indian edition 2009; 293-373.
  • Allen LV, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lippincott, Williams and Wilkins 2004.
  • Cole GC. Evaluating development and production costs: tablets versus capsules. Pharm Technol Eur 5 1998; 17-26.
  • Jones BE. The history of the gelatin capsule, in: Hard Capsules, ed. Ridgway, K., The Pharmaceutical Press 1987.
  • Loyd Allen V, Nicholas Jr, Popovich G, Howard Ansel C. Ansels pharmaceutical dosage forms and drug delivery systems. 8th Edition.
  • Ewart Cole T. Liquid filled and sealed hard gelatin capsules. Capsugel Library.
  • Karteek M, Bala Krishna K. A Review on capsules in pharmacy. Int. J. Pharm. and Tech. 2011; 3(3):1189-1196.
  • "History of dosage forms and basic preparations". Encyclopedia of Pharmaceutical Technology. 7. Informa Health Care 1998: 304–306.
  • Borgquist P, Nevsten P, Nilsson B, Wallenberg LR, Axelsson A. Simulation of the release from a multiparticulate system validated by single pellet and dose release experiments. J. of Cont. Rel. 2004; 97: 453–465.
  • Khosla R, Feely LC, Davis SS. Gastrointestinal transit of nondisintegration tablets in fed subjects. Int. J. Pharm 1989; 53:107- 117.
  • Riis T, Bauer-Brandl A, Wagner T, Kranz H. pH independent drug release of an extremely poorly soluble weakly acidic drug from multiparticulate extended release formulations. Eur. J. Pharm/ Biopharm 2007; 65: 78-84.
  • Shaji J, Chadawar V,Talwalkar P. Multiparticulate Drug Delivery System, The Indian Pharmacist 2007; 6(60): 21-28.
  • Preparing Modified Release Multiparticulate Dosage Forms With Eudragit Polymers, Pharma Polymers 2002; 9: 2-3.
  • Cole G, Hogan J, Aulton M. Pharmaceutical Coating Technology, London: Taylor and Francis 1995.
  • Gross ST, Hoffman A, Donbrow M, Benita S. Fundamentals of the release mechanism interpretation in multiparticulate systems: the prediction of the commonly observed release equations from statistical population models for particle ensembles. Int. J. Pharm 1986; 29: 213–222.
  • Hoffman A, Donbrow M, Gross ST, Benita S, Bahat R. Fundamentals of release mechanism interpretation in multiparticulate systems: determination of substrate release from single microcapsules and relation between individual and ensemble release kinetics. Int. J. Pharm 1986; 29: 195–211.
  • Mathiowitz E, Brannon-Peppas L. In: Mathiowitz, E. (Ed.), Encyclopedia of Controlled Drug Delivery. Wiley, New York 1999; 493–546.
  • Stephen Brown, Gary Norman, Alyn McNaughton. Liquid-Fill Based Formulation: Advances and Challenges. Innovations in Pharm. Technol. 64-68.
  • Duocap for controlled release combination products. Available at http://www.encapdrugdelivery.com/assets/files/services/Encap%2 0DuoCap%20Technology.pdf
  • Mangesh Bhad E, Shajahan Abdul, Sunil Jaiswal B, Anil Chandewar V, Jayesh Jain M, Dinesh Sakarkar M. MUPS Tablets – A Brief Review. Int. J. of PharmTech Res . 2010; 2 (1): 847- 855.
  • Bin Li, JiaBi Zhu, ChunLi Zheng, Wen Gong. A novel system for three-pulse drug release based on “tablets in capsule” device 2007; 1-6.
  • Ying-huan Li, Jia-bi Zhu. Modulation of combined-release behaviors from a novel ‘‘tablets-in-capsule system. J. of Con. Rel. 2004; 95: 381– 389.
  • N. G. Raghavendra Rao, Mohd Abdul Hadi, Harsh Panchal. A Novel approach to sustained Montelukast sodium release: Differentially coated mini-tablets in HPMC capsules. Int. J. of Pharm. and Biomed. Sci. 2011; 2(2): 90-97.
  • Mohd Abdul Hadi, Raghavendra Rao NG, Sunil firangi. Minitablets technology: An Overview. American J. of Pharm. Res. 2011; 2(2): 128-150.
  • Hitesh P. Patel, Nitesh J. Patel, Formulation and evaluation of biphasic drug delivery system of diclofenac sodium using compressed mini tablet. Int. J of Pharm Res. 2011; 3(1).
  • Mako to Ishida, Kenichi Abe., Munoru, Hashezime, Masco Kawamura. A novel approach to sustained pseudoephedrine release-Differentially coated Mini-tablets in HPMC capsules. Int. J. of Pharm. 2008; 359: 46-52.
  • Raghavendra Rao NG, Mohd Abdul Hadi, Mansoori Wahid, Munde MR, Shrishail M. Ghurghure, Development and evaluation of tablets-filled-HPMC capsule system for chronotherapeutic delivery of montelukast sodium. Int. J. of Pharm. and Tech. 2011; 3(1):1702-1721.
  • Ogura T, Furuya Y, Matuura S. HPMC capsules: an alternative to gelatin. Pharm Tech Europe , 2011; 10(11): 32-42.
  • Brown J, Madit N, Cole ET, Wilding IR, Cade D. Effect of crosslinking on the in vivo disintegration of hard gelatin capsules. Pharm. Res 1998; 15: 1026–1030.
  • Liebowitz, SM., Vadino WA., Ambrosio TJ. Determination of hard gelatin capsule brittleness using a motorized compression test stand. Drug Dev. Ind. Pharm 1990; 16: 995–1010.
  • Subal Basak C. The rise and rise of HPMC capsules. September 2007. Available at www.pharmabiz.com
  • Digenis GA, Gold TB, Shah VP. Crosslinking of gelatin capsules and its relevance to their in-vitro in-vivo performance, J. Pharm. Sci.1994; 83: 7.
  • Rowe, R.C., Sheskey, P.S. Weller, P.J.Handbook of Pharmaceutical Excipients, 5th Edn. Pharmaceutical Press (London, UK) and the American Pharmacists Association, Washington DC, USA 2003.
  • Nature caps, cellulose (HPMC) capsules, product brochure, ACG World wide. Available at www.acg-word.com
  • Nagata S, Tochio S, Sakuma S, Suzuki Y. Dissolution profiles of drugs filled into HPMC capsule and gelatin capsule. Abstract presented at: AAPS Annual Meeting in Denver; W4196,
  • Hard capsule for pharmaceutical drugs and method for producing the same. US Patent No. 5264223; November 23, 1999.
  • Hard capsule for pharmaceutical drugs and method for producing the same. U.S Patent No. 543917; July 11, 1995.
  • Capsule shell. May 26, 1998, US Patent No. 5756123.
  • Nagata S, Nishi N, Matsuura S. Characteristics of HPMC capsules. Abstract 161 (Scientific to Regulatory Approaches) presented at: International Symposium on Strategies for Optimizing Oral Drug Delivery in Kobe 1999; 19-21:161.
  • Sherry Ku M, Weiyi Li,, Wendy Dulin, Fran Donahue, Dominique Cade, Hassan Benameur, Keith Hutchison. Performance Qualification of a New Hypromellose Capsule. Capsugel Library. BAS 401.
  • Cole GC. Hard Capsules-development and technology, edited by K Ridgway, The pharmaceutical Press. 1987; 93: 165-169.
  • David Edwards. Applications of capsule dosing techniques for use in dry powder inhalers. Therapeutic del 2010; 1(1): 195-201.
  • Jones BE. Manufacture and properties of two piece hard capsules, in: F. Podczek, BE. Jones (Eds.), Pharmaceutical Capsules, Pharmaceutical Press, London 2004; 79–100.
  • Augsburger LL. Hard and Soft Shell Capsules, in Banker GS and Rhodes CT (eds), Modern Pharmaceutics, 2002; Volume 121, Marcel Dekker, Inc, New York.
  • Grosswald RR, Anderson JB and Andrew CS. Method for the manufacture of pharmaceutical cellulose capsules. US Patent No. 1997; 5,698,155.
  • Grosswald RR, Anderson JB and Andrew CS. Apparatus for the manufacture of pharmaceutical cellulose capsules. US Patent No. 5,750,157.
  • Grosswald RR, Anderson JB and Andrew CS. Method for the manufacture of pharmaceutical cellulose capsules. US Patent No. 1998; 5,756,036.
  • Grosswald RR, Anderson JB and Andrew CS. Method for the manufacture of pharmaceutical cellulose capsules. US Patent No. 2002; 6,337,045.
  • Dr Fahan Jalees ahmed, Sushma Drabu, Smriti Khatri, Sheveta Babu. Formulation and Evaluation of Acyclovir Capsules. Int. J. of Drug Dev. and Res. 2004;3(4): 162-167.
  • Ashok K. Gupta. Introduction to pharmaceutics-, 3rd Edition , 2006; 275-283.
  • Quality Control of solid dosage forms. Pharos University in Alexandria. Faculty of pharmacy and drug manufacturing. Industrial QC and GMP (PHR 505): 1-4.
  • Teja CH, Balamuralidhara V, Vinay S, Sudeendra Bhatt R, Pramod Kumar TM. Comparative study of in-process and finished products quality control tests of Indian pharmacopoeia, british pharmacopoeia and united states pharmacopoeia for capsules and liquid orals. Int. Res. J. of Pharm. 2011; 2(9): 65-69.
  • Yamamoto T, Matsuura S, Hashimoto K, Abe K and Akal A. Hard capsules. European Patent No. EP0592130B1, 1999; 28. 59. US Pharmacopoeia 30-NF25, , 2007; May 1.
  • Kupiec TC, Vu N, Branscum D. Homogeneity of dosage forms. Int. J. of Pharm. Comp. 2008;12(4): 340-343.

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  • Impact of Capsules as a Carrier for Multiple Unit Drug Delivery and the Importance of HPMC Capsules

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Authors

Mohd Abdul Hadi
Dept of Pharmaceutics, Bhaskar Pharmacy College, Yenkapally (V), Moinabad (M), R.R. District, Hyderabad-500075, India
N. G. Raghavendra Rao
Dept of Pharmaceutics, Jyothismathi Institute of Pharmaceutical Sciences, Thimmapur, LMD Colony, Karimnagar-505481, Andhra Pradesh,, India
A. Srinivasa Rao
Dept of Pharmaceutics, Bhaskar Pharmacy College, Yenkapally (V), Moinabad (M), R.R. District, Hyderabad-500075, India
Gaddam Shiva
Dept of Pharmaceutics, Bhaskar Pharmacy College, Yenkapally (V), Moinabad (M), R.R. District, Hyderabad-500075, India
J. Waseem Akram
Dept of Pharmaceutics, Bhaskar Pharmacy College, Yenkapally (V), Moinabad (M), R.R. District, Hyderabad-500075, India

Abstract


The word 'capsule' is derived from the latin capsula, meaning a small box. It is a solid oral dosage form in which the active ingredients and diluents are contained in a two-piece hard shell, usually made of gelatin. In the development of new medicines, there are several problems to be solved. The formulation, and its important stability and releasecharacteristics, control and reproducibility of the production process are other factors to be taken into account and, increasingly, research costs and development timeframes have also to be considered. When it comes to a decision at the end of phase II, which dosage form will be developed for the market, high production costs of hard gelatin capsule products are generally assumed. Multiple unit dosage forms are mainly oral dosage forms consisting of a multiplicity of small discrete units, each exhibiting some desired characteristics. It is even possible to include a number of dosage forms - such as tablets, pellets, capsules, powders and granules - within a single formulation. In this way, incompatibilities and interaction between the different drug substances in combination products can be prevented. Hard gelatin capsules are particularly suitable for their development and manufacture. Hard gelatin capsules do have some drawbacks. To overcome these problems, pharmaceutical scientists have developed capsules made of starch, cellulose derivatives and polyvinyl alcohol copolymer. To date, HPMC capsules have been successfully utilized for pharmaceutical products.

Keywords


Capsule, Solid Oral Dosage Form, Multiple Unit Dosage Form, HPMC

References