Polymers in Medicine

Polim. Med.
Scopus CiteScore: 3.5 (CiteScore Tracker 3.6)
Index Copernicus (ICV 2023) – 121.14
MEiN – 70
ISSN 0370-0747 (print)
ISSN 2451-2699 (online) 
Periodicity – biannual

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Polymers in Medicine

2015, vol. 45, nr 1, January-June, p. 21–24

Publication type: original article

Language: English

Creative Commons BY-NC-ND 3.0 Open Access

Dissolution Studies of Papaverine Hydrochloride from Tablets in Three Pharmacopoeia Apparatuses

Andrzej Polski1,A,B,C,D,E,F, Regina Kasperek1,C,D,E,F, Magdalena Rogowska1,A,B,C, Karol Iwaniak1,A,B,C, Karolina Sobótka-Polska2,A,D, Ewa Poleszak1,E,F

1 Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland

2 Department of Organic Chemistry, Medical University of Lublin, Lublin, Poland

Abstract

Background. In tablet production, the most important aspects are the physical properties of the tablets and their dissolution studies, which can be performed in four pharmacopoeial apparatuses. There are differences between them in construction and action, so differences in the results obtained are possible.
Objectives. The aim of the study was to compare the release of a model drug substance (papaverine hydrochloride) from tablets in three pharmacopoeial dissolution apparatus: a basket, a paddle (closed system) and flow-through cell (open system).
Material and Methods. The one series of tablets were produced by direct compression in a tablet press. The physical properties of the tablets (weight and size uniformity test, friability and hardness tests, disintegration time test), drug content and the release study of papaverine hydrochloride from tablets were studied in three dissolution apparatuses. The content of the active substance was studied spectrophotometrically.
Results. All tablets met the pharmacopoeic requirements. Over 80% of the model substance released from the tablets after 14 min in flow through the cell apparatus, while in the basket and paddle apparatuses after about 7 min 30 sec. After 20 min, the amount of the substance released in all apparatuses was over 90%.
Conclusion. The release profiles of the drug substance in paddle and basket apparatuses were similar, while in the flowthrough cell apparatus it was slightly slower. When the study conditions and composition of the tablets are the same, the release profile of the drug can be affected by the type of dissolution apparatus.

Key words

tablets, release study, papaverine hydrochloride, pharmacopoeia dissolution apparatus

References (18)

  1. Pifferi G., Santoro P., Pedrani M.: Quality and functionality of excipients. Farmaco 1999, 54, 1–14.
  2. Lunio R., Sawicki W., Skoczen W., Walentynowicz O., Kubasik-Juraniec J.: Compressibility of gastroretentive pellets coated with Eudragit NE using a single-stroke and rotary tablet press. Pharm. Dev. Technol. 2008, 13, 323–331.
  3. Kraciuk R., Sznitowska M.: Effect of different excipients on the physical characteristics of granules and tablets with carbamazepine prepared with polyethylene glycol 6000 by fluidized hot-melt granulation (FHMG). AAPS Pharm. Sci. Tech. 2011, 12, 1241–1247.
  4. Janicki S.: Dostępność farmaceutyczna i dostępność biologiczna leków. OIN Polfa, Warszawa 2001.
  5. Janicki S.: Farmacja stosowana: podręcznik dla studentów farmacji. PZWL, Warszawa 2003.
  6. Polish Pharmacopoeia IX. Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, PTF Warszawa 2011.
  7. Fotaki N., Aivaliotis A., Butler J., Dressman J., Fischbach M., Hempenstall J., Klein S., Reppas C.: A comparative study of different release apparatus in generating in vitro-in vivo correlations for extended release formulations. Eur. J. Pharm. Biopharm. 2009, 73, 115–120.
  8. Sznitowska M., Pietkiewicz P., Dorosz A., Lukasiak J., Vermeiere A., Remon J. P.: Dissolution of lithium carbonate from three types extended-release capsules in paddle, basket and flow-through apparatus. Curr. Issues Pharm. Med. Sci. 2012, 25, 164–167.
  9. Weennergren B., Lindberg J., Nicklasson M., Nilsson G., Nyberg G., Ahlgren R., Persson C., Palm B.: A collaborative in vitro dissolution study: comparing the flow-through method with the USP paddle method using USP prednisone calibrator tablets. Int. J. Pharm. 1989, 53, 35–41.
  10. Chevalier E., Viana M., Artaud A., Chomette L., Haddouchi S., Devidts G., Chulia D.: Comparison of three dissolution apparatuses for testing calcium phosphate pellets used as ibuprofen delivery systems. AAPS PharmSciTech 2009, 10, 597–605.
  11. Marczyński Z.: Technologia tabletkowania suchego wyciągu z ziela nawłoci pospolitej (Solidago virgaurea L.) przy użyciu silifikowanej celulozy mikrokrystalicznej (Prosolv) oraz innych wybranych substancji pomocniczych. Polim. Med. 2009, 39, 51–60.
  12. Martindale: The Complete Drug Reference. [online] London: Pharmaceutical Press http://www.medicinescomplete.com (Accessed 09.01.2015).
  13. Kaneda T., Hayasaka R., Nagai Y., Tajima T., Urakawa N., Nakajyo S., Shimizu K.: Effect of papaverine on twiches in mouse diaphragm. Pharmacology 2010, 86, 273–280.
  14. Pharmindex Brevier Podręczny indeks leków. UBM Medica Polska Sp. z. o. o. Warszawa 2013.
  15. Miyajima M., Koshika A., Okada J., Kusai A., Ikeda M.: Factors influencing the diffusion-controlled release of papaverine from poly(L-lactic acid) matrix. J. Control. Release. 1998, 56, 85–94.
  16. Serajuddin A. T., Rosoff M.: pH-solubility profile of papaverine hydrochloride and its relationship to the dissolution rate of sustained-release pellets. J. Pharm. Sci. 1984, 73, 1203–1208.
  17. Marzec A.: Badanie dostępności i równoważności biologicznej. OINPHARMA, 2007.
  18. Abdou H.: Dissolution. Bioavailability & Bioequivalence. Mack Printing Company, Easton, Pensylvania 1989.
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