Compatibility studies between propafenone and selected excipients used in the development of controlled release formulations

Main Article Content

Mahammad S Shahe
Madhusudhana Chetty
KV Ramana Murthy

Abstract

The objective of the present study was to evaluate the compatibility of propafenone HCl (PFH) with the selected excipients used in a controlled drug delivery system. The studies were conducted by an isothermal stress test method.
The differential scanning calorimetry (DSC) and high-performance liquid chromatography techniques were used as tools to assess the compatibility of the drug with the selected excipients. Complementary techniques such as powder X-ray powder diffractometry (pXRD) and fourier transform infrared (FTIR) spectroscopy were used to assist in the interpretation of the DSC results. On the basis of the DSC results, the drug was found to be compatible with gum kondagogu (GKG), chitosan, polyelectrolyte complex of GKG and chitosan, HPMC K100M, carbopol 934P, Benecel® and A-tab®. Some degree of interaction was observed with lactose monohydrate; however, the additional studies using FTIR spectroscopy and pXRD confirmed that PFH is compatible with lactose monohydrate.

Downloads

Download data is not yet available.

Article Details

How to Cite
Shahe, M. S., Chetty, M., & Murthy, K. R. (2014). Compatibility studies between propafenone and selected excipients used in the development of controlled release formulations. Asian Journal of Pharmaceutics (AJP), 6(2). https://doi.org/10.22377/ajp.v6i2.66
Section
Articles

References

Chow MS, Lebsack C, Hilleman D. Propafenone: A new antiarrhythmic

agent. Clin Pharm 1988;7:869-77.

Available from: http://www.drugs.com/mtm/propafenone.html. [Last

accessed on 2011 Oct 11].

Mora PC, Cirri M, Mura P. Differential scanning calorimetry as a

screening technique in compatibility studies of DHEA extended release

formulations. J Pharm Biomed Anal 2006;42:3-10.

Verma RK, Garg S. Compatibility studies between isosorbide mononitrate and selected excipients used in the development of

extended release formulations. J Pharm Biomed Anal 2004;35:449-58.

Vinod VT, Sashidhar RB, Suresh KI, Rama Rao B, Vijaya Saradhi UV,

Prabhakar Rao T. Morphological, physico-chemical and structural

characterization of gum kondagogu (Cochlospermum gossypium):

A tree gum from India. Food Hydrocolloid 2008;22:899-915.

Vinod VT, Sashidhar RB, Sarma VU, Vijaya Saradhi UV. Compositional

analysis and rheological properties of gum kondagogu (Cochlospermum

gossypium): A tree gum from India. J Agric Food Chem 2008;56:

-207.

Janaki B, Sashidhar RB. Physico-chemical analysis of gum kondagogu

(Cochlospermum gossypium): A potential food additive. Food Chem

;61:231-6.

Janaki B, Sashidhar RB. Subchronic (90-day) toxicity study in rats fed

gum kondagogu (Cochlospermumgossypium). Food Chem Toxicol

;38:523-34.

Ramana Murthy KV, Seshasayana A. Novel pharmaceutical compositions

and controlled release drug delivery systems based on novel

polysaccharide excipient (Hupu Gum). Indian patent, 229191 (952/

CHE/2003); February 13, 2009.

Malafaya PB, Silva GA, Reis RL. Natural-origin polymers as carriers

and scaffolds for biomolecules and cell delivery in tissue engineering

applications. Adv Drug Deliver Rev 2007;59:207-33.

Berth G, Dautzenberg H, Peter MG. Physico-chemical characterization

of chitosans varying in degree of acetylation. Carbohydr Polym

;36:205-16.

Dutta PK, Dutta J, Tripathi VS. Chitin and chitosan: Chemistry, properties and applications. J Sci Ind Res 2004;63:20-31.

Felse PA, Panda T. Studies on applications of chitin and its derivatives.

Bioproc Biosyst Eng 1999;20:505-12.

Araajo AA, Storpirtis S, Amp X, Mercuri LP. Thermal analysis of the

antiretroviral zidovudine (AZT) and evaluation of the compatibility with

excipients used in solid dosage forms. Int J Pharm 2003;260:303-14.

Zohuriaan MJ, Shokrolahi F. Thermal studies on natural and modified

gums. Polym Test 2004;23:575-9.