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Abstract

A FACTORIAL STUDY ON ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF EFAVIRENZ EMPLOYING β- CYCLODEXTRIN, SOLUPLUS AND PVPK30

K.Ravi Shankar1 and K.P.R. Chowdary* 2

1A.KR.G College of Pharmacy, Nallajerla - 534112, A.P. India
2Former Principal, A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam- 530003, A.P.

ABSTRACT

Efavirenz, a widely prescribed anti retroviral drug belongs to class IΙ under BCS and exhibit low and variable oral bioavailability due to its poor aqueous solubility. Its oral absorption is dissolution rate limited and it requires enhancement in the solubility and dissolution rate for increasing its oral bioavailability. The objective of the study is to enhance the solubility and dissolution rate of efavirenz by cyclodextrin complexation along with Soluplus and PVP K30 and to evaluate the individual main effects and combined (or interaction) effects of β cyclodextrin (βCD), surfactant (Soluplus) and PVP K30 on the solubility and dissolution rate of efavirenz in a series of 23 factorial experiments. The solubility of efavirenz in eight selected fluids containing βCD, Soluplus and PVP K30 as per 23 factorial study was determined. Solid inclusion complexes of efavirenz-βCD were prepared with and without Soluplus and PVP K30 by kneading method as per 23-factorial design and were evaluated. The individual and combined effects of βCD, Soluplus and PVP K30 in enhancing the solubility, dissolution rate and dissolution efficiency of efavirenz were highly significant (P < 0.01). βCD alone gave a 2.14 fold increase in the solubility of efavirenz. Combination of βCD with Soluplus and PVP K30 resulted in a much higher enhancement in the solubility of efavirenz, 86.96 fold with βCD- Soluplus and 4.85 fold with βCD- PVP K30, than with βCD alone. Soluplus alone gave a much higher enhancement (289.49 folds) in the solubility of efavirenz. Combination of βCD with Soluplus and PVP K30 also gave significantly higher dissolution rates (K1) and dissolution efficiency (DE20) when compared to βCD alone. βCD alone gave 2.00 fold increase and in combination with Soluplus and PVP K 30, it gave respectively 7.34 and 7.98 fold increase in the dissolution rate of efavirenz. Soluplus and PVP K30 alone also gave a higher enhancement in the dissolution rate and dissolution efficiency of efavirenz. Hence a combination of βCD with Soluplus and / or PVP K30 or Soluplus and PVP K30 alone is recommended to enhance the solubility, dissolution rate and dissolution efficiency of efavirenz , a BCS class II drug.

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