Preparation and evaluation of drotaverine hydrochloride orally disintegrating tablets using melt granulation

Hari Kuralla; Rajeswari Saripilli; Venkata Ramana Murthy Kolapalli

doi:10.7324/JAPS.2018.81006

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Abstract

The objective of the present study is to formulate and evaluate orally disintegrating taste masked drotaverine hydrochloride (HCl) tablets prepared by the melt granulation technique. Taste-masked drug-polymer melt granules of drotaverine HCl were prepared by using either compritol 888 ATO (compritol) or precirol ATO 5 (precirol) using varying drug-polymer ratios of 1:1, 1:2, 1:5, and 1:7. Prepared drug-polymer blends were evaluated for taste masking and the ratio of drug-polymer is optimized. The drug-polymer ratios 1:7 with compritol and 1:5 with precirol were optimized based on taste evaluation. The granules and tablets prepared with optimized drug-polymer ratio were evaluated for pre- and post-compression parameters. From all the prepared taste masked drotaverine HCl tablets, formulations CP9 and PF5 were optimized based on taste, mouthfeel, dissolution, and other oral disintegrating tablet (ODT) parameters. Formulations CP9 and PF5 showed the release of >50% drug in 5 minutes and 100% of the drug in 45 and 30 minutes, respectively. The optimized formulations were characterized by Fourier transformed infrared spectroscopy, differential scanning calorimetry, and XRD studies and found no incompatibility. The results demonstrated that the prepared drotaverine HCl ODT showed better taste masking meeting the parameters of ODT formulations PF5 > CP9. The present melt granulation technique can be effectively used for taste masking.

Keyword: Drotaverine HCl Compritol Precirol Melt granulation Taste masking ODT.

Citation:

Kuralla H, Saripilli R, Kolapalli VRM. Preparation and evaluation of drotaverine hydrochloride orally disintegrating tablets using melt granulation. J App Pharm Sci, 2018; 8(10): 039-046.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Reference

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Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier J, Piccerelle P. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int J Pharm, 2005; 292:29–41. https://doi.org/10.1016/j.ijpharm.2004.08.019
Anusha P, Nirajana A, Mohammed S, Jilani S, Murali C, Harish G. Development and evaluation of drotaverine taste masked tablets with improved dissolution efficiency using sold dispersion technique. IJRPB, 2013; 1:275–80.
Ashwini M, Shivajirao K, Varsha P. Studies on formulation development of mucoadhesive sustained release itraconazole tablet using response surface methodology. AAPS Pharm Sci Tech, 2008; 9:998–1005. https://doi.org/10.1208/s12249-008-9119-8
Bi YX, Sunada H, Yonezawe Y, Danzo K. Evaluation of rapidly disintegrating tablets. Drug Dev Ind Pharm, 1999; 25:571–81. https://doi.org/10.1081/DDC-100102211
Craick DJ. The flow properties of starch powders and mixtures. J Pharm Pharmacol 1958; 10:10. https://doi.org/10.1111/j.2042-7158.1958.tb10275.x
Indian Pharmacopoeia. Govt of India, Ministry of Health and Family Welfare, the Indian Pharmacopeia Commission, Ghaziabad, India, pp 187–93, 2010.
Katsuno E, Tahara K, Takeuchi Y, Takeuchi H. Orally disintegrating tablets prepared by a co-processed mixture of micronized crospovidone and mannitol using a ball mill to improve compatibility and tablet stability. Powder Technol, 2013; 241:60–6. https://doi.org/10.1016/j.powtec.2013.03.008
Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Formulation evaluation of mouth dissolving tablets of fenofibrate using sublimation technique. Int J Chem Tech Res, 2009; 1:840–50.
Pandey B, Mallik S, Ahmad S. Coprocessing of super disintegrants for drug release of taste masked Drotaverine HCl. Novel Sci IJPS, 2012; 1:758–63.
Pankaj A, Sanjay P, Abhijeet T, Manoj W, Parag K, Rajendra S. Design and evaluation of taste masked chewable dispersible tablet of lamotrigine by melt granulation. Int J Drug Delivery, 2010; 2:183–91. https://doi.org/10.5138/ijdd.2010.0975.0215.02028
Raghavendra N, Mahesh K, Srikanth M, Kistayya C, Mahipal B. Development and evaluation of fast dissolving tablets of fosinopril by sublimation method. Int J Pharm Sci Drug Res, 2012; 4:230–35.
Sivaprasad S, Hindustan A, Sreenivasulu R, Kishore R, Krishna CH, Kranthi G, et al. Novel approach in designing of mouth dissolving tablets for bitter drugs taking clozapine as model drug. Der Pharmacia Lett, 2011; 3:113–20.
Srikanth M, Uhumwangho M, Sunil S, Sreenivasa N, Ravi C, Ramana Murthy K. Design and evaluation of taste masked Drotaverine HCl orodispersible tablets using polymethacrylate polymers. Der Pharmacia Lett, 2010; 2:223–31.
Subrahmanian S, Sankar V, Asha A. Formulation and evaluation of cetirizine dihydrochloride orodispersible tablet. Pak J Pharm Sci, 2010; 23:232–35.
Tran D. Some aspects of the property of angle of repose of powders. J Pharm Pharmacol, 1957; 1:127–35.
Uchida T, Nakamura T, Tanigake A. The effect of various substances on the suppression of the bitterness of quinine-human gustatory sensation, binding and taste sensor studies. Chem Pharm Bull (Tokyo), 2002; 50:1589–93. https://doi.org/10.1248/cpb.50.1589
Uddhav B, Kishore G, Nancy P, Sanjeevani A, Shalaka D. Formulation and evaluation of sublimed fast melt tablets of levocetirizine dihydrochloride. IJPSR, 2010; 2:76–80.
Ujwala B, Dinesh S, Sarika Z, Varsha K, Nanda R. Development and evaluation of drotaverine taste masked tablets with improved dissolution efficiency using sold dispersion technique. Res J Pharm Tech, 2014; 7:301–6.
USP30-NF25. The official compendia of standards. The United States Pharmacopoeial Convention. Powder flow (e book), 2007; 643.
USP30-NF25. The official compendia of standards. The United States Pharmacopoeial Convention. Bulk Dens Tapped Dens (e book), 2007; 242.
Yoshinari T, Forbes RT, York P, Kawashima Y. Moisture induced polymorphic transition of mannitol and its morphological transformation. Int J Pharm, 2002; 247:69–77. https://doi.org/10.1016/S0378-5173(02)00380-0

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