HPMC AS CAPSULE SHELL MATERIAL: PHYSICOCHEMICAL, PHARMACEUTICAL AND BIOPHARMACEUTICAL PROPERTIES
DOI:
https://doi.org/10.22159/ijpps.2017v9i10.20707Keywords:
Gelatin, HPMC, Formaldehyde challenge test, In vitro dissolution, Stability studyAbstract
The most common instability problem of gelatin capsules arises from negative impact of extremes of temperature and especially atmospheric relative humidity on the mechanical integrity of the capsule shells with adverse effect extended even to the fill material. Moreover, choice of fill materials is highly restricted either due to their specific chemical structure, physical state or hygroscopicity. Additional reports of unpredictable disintegration and dissolution of filled hard gelatin capsules in experimental studies have prompted the search for a better alternative capsule shell material. The present review aims to provide an overview on the physicochemical, pharmaceutical and biopharmaceutical properties of hydroxypropyl methylcellulose (HPMC) as capsule shell material and perform comparative evaluation of HPMC and gelatin in terms of in vitro/in vivo performance and storage stability. HPMC capsule provides a highly flexible and widely acceptable platform capable of solving numerous challenges currently facing the pharmaceutical and nutraceutical industries and expands the possibilities for selection of different types of fill materials. The current topic introduces a new section on influence of various factors on in vitro dissolution of HPMC capsules. Delayed in vitro disintegration/dissolution of HPMC capsules in aqueous medium does not produce any negative effect in vivo. However, advancements in the processes of production and filling of HPMC capsule shells and detailed studies on effects of various parameters on their in vitro/in vivo dissolution would establish their supremacy over hard gelatin capsules in future.
Downloads
References
Brown S, Norman G, McNaughton A. Liquid-fill based formulation: advances and challenges. Innov Pharm Technol 2010;10:64-8.
Neeharika MS, Jeevana Jyothi B. Chronotherapeutics: an optimizing approach to synchronize drug delivery with circadian rhythm. J Crit Rev 2015;2:31-40.
Stegemann S. Hard gelatin capsules today–and tomorrow. 2nd ed. Capsugel Library, Bornem; 2002.
Bhatt B, Agrawal SS. Pharmaceutical Technology. Capsules; 2008. www.niscair.res.in/jspui/bitsream/123456789/747/1/Revised%20CAPSULES.pdf. [Last accessed on 10 May 2017]
Dey P, Ghosh A. Wafers: an innovative advancement of oro-dispersible films. Int J Appl Pharm 2016;8:1-7.
Doye P, Mena T, Das N. Formulation and bio-availability parameters of pharmaceutical suspension. Int J Curr Pharm Res 2017;9:8-14.
Sherry Ku M, Li W, Dulin W, Donahue F, Cade D, Benameur H, et al. Performance qualification of a new hypromellose capsule: part I. Comparative evaluation of physical, mechanical and processability quality attributes of Vcaps Plus, Quali-V and gelatin capsules. Int J Pharm 2010;386:30-41.
Pharmaceutical Preformulation and Formulation: a practical guide from candidate drug selection to commercial dosage form Edited by Mark Gibson CRC Press; 2009.
Modern Pharmaceutics. Fourth Edn. Gilbert S. Banker, Juergen Siepmann, Christopher Rhodes CRC Press; 2002.
Two-piece capsules for solid oral dosage form–LUFERCOMP QSA020; 2006E. Available from: www.qualicaps.com. [Last accessed on 03 Jan 2017]
Marque MRC. Enzymes in the dissolution testing of gelatin capsules. AAPS PharmSciTech 2014;15:1410–6.
Empty vegetarian capsules and empty gel capsules ingredients. Capsule connection. Available from: www. Capsule connection.com. [Last accessed on 24 Feb 2017]
Soft gelatin capsule manufacturing. Available from: www.bry-air.com [Last accessed on 22 Jan 2017]
Rabadiya B, Rabadiya P. A review: capsule shell material from gelatin to non animal origin material. Int J Pharm Res Biosci 2013;2:42-71.
Arianto A, Bangun H, Yohana A, Silalahi J. Floating gastroretentive of amoxicillin using hard alginate capsules and its antibacterial activities. Asian J Pharm Clin Res 2017;10:413-9.
Cade D. VcapsPlus® capsules: a new HPMC capsule for optimum formulation of pharmaceutical dosage forms. Available from: www.capsugel.com. [Last accessed on 12 Jan 2017].
Salih OS, Nief RA. Effect of natural and synthetic polymers on the properties of candesartan cilexetil matrix tablet prepared by dry granulation. Asian J Pharm Clin Res 2016;9 Suppl 3:161-70.
Mohite PB, Khanage SG, Harishchandre VS, Shirsath Y. Recent advances in microsponges drug delivery system. J Crit Rev 2016;3:9-16.
Sobhita Rani P, Muthu P, Kadali K. Development and in vitro drug release studies of satranidazole capsules for colon specific drug delivery. Asian J Pharm Clin Res 2014;7:203-11.
Two-piece capsules for liquid-fill formulations-LUFERCOMP QSA022-2006E. Available from: www.qualicaps. com. [Last accessed on 08 Feb 2017]
Quali-V® (Hypromellose) for Pharmaceutical Applications. Brochure from Qualicaps QI03/0; 2008. Available from: www.qualicaps.com. [Last accessed on 12 Jan 2017]
The Non-Animal Alternative EMBO CAPS® VG Hypromellose (HPMC). Available from: www.suheung.com [Last accessed on 19 Dec 2016]
Vcaps TM-HPMC offering unique solutions. 200104004. Available from: www.capsugel.com. [Last accessed on 16 Jan 2017]
Hard gelatin capsule manufacturing. Available from: http://formulation.vinensia.com/2011/04.
Joshi SC. Sol-gel behavior of hydroxypropyl methylcellulose (HPMC) in ionic media including drug release. Materials 2011;4:1861-905.
Saleem IY, Diez F, Jones BE, Kayali N, Polo P. Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels. Int J Pharm 2015;492:258–63.
Al-Tabakha MM. Current status and future prospects. J Pharm Pharm Sci 2010;13:428–42.
Robin S, Cuevas J, Cade D. HPMC Capsules sealing with capsugel CFS1200 equipment for small scale laboratory development. 201006004. Poster presented at the 2009 Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists. Los Angeles, California; 2009.
Method for banding hard capsules using hydroxypropylmethyl cellulose (HPMC) as a base EP 1 942 878 B1 European Patent specification, Bulletin; 2014. p. 17.
Richardson M. Impact of capsule selection on formulation stability in dry powder inhalers (DPIs); 2011. Available from: www.capsugel.com. [Last accessed on 05 Feb 2017]
Chong RHE, Jones BE, DÃez F, Birchall JC, Coulman SA. Evaluating the sensitivity, reproducibility and flexibility of a method to test hard shell capsules intended for use in dry powder inhalers. Int J Pharm 2016;500:316–25.
Torrisi BM, Birchall JC, Jones BE, DÃez F, Coulman SA. The development of a sensitive methodology to characterise hard shell capsule puncture by dry powder inhaler pins. Int J Pharm 2013;456:545-52.
Nagata S. Advantages to HPMC capsules: a new generation's. Drug Dev Delivery 2002;2:2.
Breaking-force tests for empty and filled hard capsules and softgels: Dr. Schleuniger Pharmatron; 2013. Available from: www.pharmatron.com/newsroom/news. [Last accessed on 03 Mar 2017]
Barham AS, Tewes F, Healy AM. Moisture diffusion and permeability characteristics of hydroxypropylmethylcellulose and hard gelatin capsules. Int J Pharm 2015;478:796-803.
Glube N, Moos L, Duchateau. Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract. Results Pharma Sci 2013;3:1–6.
Cade D. Next generation HPMC capsules greatly expand pharmaceutical uses. Available from: www.capsugel.com [Last accessed on 03 Jan 2017]
Chiwele I, Jones BE, Podczeck F. The shell dissolution of various empty hard capsules Chem. Pharm Bull 2000;48:951-6.
Gray VA. Two tier dissolution testing. DuPont Merck Pharmaceuticals, Wilmington, DE, Dissolution Technologies; 1988.
Published
How to Cite
Issue
Section
