Formulation and modifying drug release from Hard and Soft Gelatin Capsules for Oral drug delivery

Authors

  • V. Deva Prasad Council of Scientific and Industrial Research (CSIR), Indian Institute of Integrative Medicine (IIIM) Jammu, India

DOI:

https://doi.org/10.21276/IJRDPL.2278-0238.2017.6(4).2663-2677

Keywords:

Buccal drug delivery, folding endurance, index, in-vitro drug release, Permeation enhancers, swelling, Thiolated polymer

Abstract

Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms in which one or more medicinal and inert ingredients are enclosed in a small shell or container usually made of gelatin. There are two types of capsules, “hard” and “soft”. The hard capsule is also called “two pieces” as it consists of two pieces in the form of small cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of the longer piece, called the “body”. The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell. The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most frequently utilized dosage. This proves the oral bioavailability of poorly soluble compounds, delivery of low and ultra-low doses of a compound using softgel also ensures decreased plasma variability. This has led to the commercial pharmaceutical and nutraceutical industries opting for the development of alternative shell forming materials instead of the traditional capsule shell material gelatin. This review discusses establishment and the ongoing development of the manufacturing technology for liquid and semisolid capsules with focus on progress and challenges of soft and hard gelatin capsules formulation in oral administration for improved solubility and as an absorption-enhancing technique. These considerations form a basis for new applications in oral drug delivery.

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References

Reich G, Podczeck F and Jones BE. Formulation and physical properties of soft capsules. 2004, - Medical - 272 pages

Bussemer T and Bodmeier R. Formulation parameters affecting the performance of coated gelatin capsules with pulsatile release profiles. International Journal of Pharmaceutics 2003, 267: 59–68.

Softgel Technologies People, facilities and technologies to deliver superior softgel solutions. http://www.catalent.com/pharma/pdf/Softgel_Technologies_Oral _Technologies. Accesed 2010/11/19.

Nazzal S. and Wang Y. Characterization of soft gelatin capsules by thermal analysis International Journal of Pharmaceutics 2001, 230: 35–45

Karim AA and Bhat R. Fish gelatin: properties, challenges, and prospects as an alternative to mammalian gelatins. FoodHydrocolloids 2009, 23: 563–576.

Marques MRC, Cole E, Kruep D, Gray V, Murachanian D, Brown WE and Giancaspro GI. Liquid-filled Gelatin Capsules. PharmacopoeialForum 2009 Vol. 35(4).

Pearnchob N, Dashevsky A and Bodmeier R. Improvement in the disintegration of shellac-coated soft gelatin capsules in simulated intestinal fluid. Journal of Controlled Release 2004, 94: 313– 321

Shanker G and Tabibi E. Water insoluble Drug Formulation, 2nd Edition, CRC Press 2008.

R & D progress of hollow capsules - capsule, new materials, coating materials -the pharmaceutical industrie. http://news.frbiz.com/pharmaceutical_excipients_ply. Accessed 2010/12/21.

Rossi RC, Dias CL, Donato EM, Martins LA, Bergold AM and Froehlich PE. Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data. InternationalJournal of Pharmaceutics 2007, 338: 119–124.

Pharmaceutics – The Science of Dosage form Design by M.E. Aulton, 2nd Edition.

Remington – The Science and Practice of Pharmacy, 20th Edition, Volume – 1.

The Theory and Practice of Industrial Pharmacy by Leon Lachman.

Encycloprdia of Pharmaceutical Technology, Volume – 2.

Website – www.capsugel.com

Website – www.liquidcapsules.com

Ogura T, Furuya Y, Matuura S. HPMC capsules: an alternative to gelatin. Pharm Tech Europe. 1998; 10(11): 32-42.

Gelatin. Gelatin Manufacturer’s Institute of America.

Hard Gelatin and Hypromellose (HPMC) Capsules: Estimation of Rupture Time by Real-timeDissolution Spectroscopy: Yasser El-Malah; Sami Nazzal;Carey B. Bottom.Publishedin:DrugDevelopment and Industrial Pharmacy, Volume 33, Issue 1 January 2007 , pages 27 - 34

Pharmabiz.com: Hard gelatin packs for liquids, May 12, 2005

Colea ET, Cadé D, and Benameur H. Challenges and opportunities in the encapsulation of liquid and semi-solid formulations into capsules for oral administration, Advanced Drug Delivery Reviews 2008, 60: 747–756.

Riff DS, Duckor S, Gottlieb I, Diamond E, Soulier S, Raymond G and Boesing SE. Diclofenac Potassium Liquid-Filled Soft Gelatin Capsules in the Management of Patients with Postbunionectomy Pain. Clinical Therapeutics 2009, 31:10.

Donato EM, Martins LA, Froehlich PE and Bergold AM. Development and validation of dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data, Journal of Pharmaceutical and Biomedical Analysis 2008, 47: 547–552.

Azarmia S, Roa W and Lobenberg R. Current perspectives in dissolution testing of conventional and novel dosage forms. International Journal of Pharmaceutics 2007, 328: 12–21.

Horter D and Dressman JB. Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Advanced DrugDelivery Reviews 2001, 46: 75–87.

Lissy M, Scallion R and Stiff DD. Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled Soft gelatin capsules with a diclofenac potassium tablet. Expert opinpharmacother 2010, 11(5):701-8

Scallion R and Moore KA. Effects of Food Intake on the Pharmacokinetics of Diclofenac Potassium Soft Gelatin Capsules: A Single-Dose, Randomized, Two-Way Crossover Study, ClinicalTherapeutics 2009, 31:10.

Ciper M and Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. International Journal of Pharmaceutics 2005, 303: 62–

Lissy M, Scallion R and Stiff DD. Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled Soft gelatin capsules with a diclofenac potassium tablet. Expert opinpharmacother. 2010, 11(5):701-8.

Vegicaps Softgel Technologies People, facilities and technologies to deliver superior softgel solutions. Copyright 2007 Catalent Pharma Solutions.

Sima JS, Juna G, Toidab T, Choc SY, Woong D, Seung-Yeup C, Linhardtd RJ and Kima YS. Quantitative analysis of chondroitin sulfate in raw materials, ophthalmic solutions, soft capsules and liquid preparations. Journal of Chromatography B, 2005, 818: 133– 139.

Martins GZ, Souza CRF, Shankar TJ and Oliveira WP. Effect of process variables on fluiddynamics and adhesion efficiency during spouted bed coating of hard gelatine capsules. Chemical Engineering and Processing 2008, 47: 2238–2246.

Yang D, Li Y and Nie J. Preparation of gelatin/PVA nanofibers and their potential application in controlled release of drugs. Carbohydrate Polymers 2007, 69: 538–543.

Dennis Murachanian. Two piece hard capsules for pharmaceutical Formulations journal of GXP Complaince summer 2010 volume 14 number 3.

Babak ziaie , Smart pill capsule will reaches the future drug delivery (www.youtube.com)

Frutos G, Prior-Cabanillas A, París R and Quijada-Garrido I. A novel controlled drug delivery system based on pH-responsive hydrogels included in soft gelatin capsules. Acta Biomaterialia 2010, 6 (12): 4650-4656

Fuccella LM, Tosolini G, Moro E and Tamassia V. Study of physiological availability of temazepam in man, Int. J clinPharmacol. 1972, 6 (4):303-309.

Lucas RA, Bowtle WJ and Ryden R. Disposition of Vancomycin.in healthy volunteers from oral solution and Semi-solid matrix capsules. Clin.Pharm.ther. 1987, 12: 27-31.

Gershanik T and Benita S. Self-dispersing lipid formulations for improving oral absorption of lipophilic drugs. European Journal ofPharmaceutics and Biopharmaceutics 2000, 50: 179-188

Mei X, Etzler FM and Wang Z. Use of texture analysis to study hydrophilic solvent effects on the mechanical properties of hard gelatin capsules. International Journal of Pharmaceutics. 2006, 324: 128–135.

LA Augsburger (1995) “Hard and soft gelatin capsules” in Modern Pharmaceutics GS Banker & CT Rhodes, Eds., Marcel Dekker, Inc.: New York, NY, pp 395–440

N Granger (1980) “Pharmaceutical compositions” U.S. Patent 4 198 391, R.P. Scherer Ltd

MS Patel, FSS Morton, & H Seager (1989) “Advances in softgel formulation technology” ManufChem, July 26–28

M Salonen, E Aantaa, L Aaltonen, M Hovi-Viander, & J Kanto (1986) “A comparison of the soft gelatin capsule and the tablet form of temazepam” Acta PharmacolToxicol58 49–54.

Published

2017-07-15

How to Cite

Prasad, V. D. . (2017). Formulation and modifying drug release from Hard and Soft Gelatin Capsules for Oral drug delivery. International Journal of Research and Development in Pharmacy & Life Sciences, 6(4), 2663 - 2677. https://doi.org/10.21276/IJRDPL.2278-0238.2017.6(4).2663-2677