Controlled Release Matrix Uncoated Tablets for Enalapril Maleate (EM)

Controlled Release Matrix Uncoated Tablets for Enalapril Maleate (EM)

Enalapril maleate is an ACE inhibitor which is used to control hypertension by inhibiting the degradation of angiotensin II.bangalore hpmc Due to low oral bioavailability and short biological half life, it requires continuous drug administration which complicates the therapy management [1].bangalore hpmc The present study was aimed to formulate controlled release matrix uncoated tablets for EM using varying viscosity grades of HPMC for improving the drug release and dissolution profile.

The optimum formulation was prepared by modifying the drug-to-polymer ratio and swelling index by performing a multiple factor design using JMP(r) 11 by SAS software.bangalore hpmc A total of eight experimental batches were formulated and evaluated.bangalore hpmc The formulations Hb2 (2%) of HPMC K100CR patches and Pb4 (4%) of HPMC K15 patches were optimised as they showed satisfactory release and were suitable for further studies like egg membrane and ex vivo tests.

All materials except EM and HPMC were gift samples from Kemwell (Kemwell Pvt Ltd, Bangalore) and Colorcon (Colorcon, Madgoa, Goa).bangalore hpmc Sodium sulfate was purchased from Loba Chemie (Mumbai), mannitol was obtained from Atul Limited, spray dried lactose was from Microlabs (Bangalore) and acetonitrile, polyvinylpyrrolidone k-30, iso propyl alcohol and magnesium stearate was procured from SD Fine –Chem (Mumbai).

The resulting films were characterized for their thickness, adhesion, retension time, tensile strength and swelling properties.bangalore hpmc All the patches exhibited acceptable thickness, adhesion and retension times. The tensile strength of the patches was found to be higher for the HPMC K100CR formulations than for the HPMC K15 formulations. Similarly, the swelling index was higher for the HPMC K100CR formulations, but lower for the HPMC K15 formulations. The released drug was found to follow Higuchi model and showed linearity with time. The r2 value of the Higuchi fit was 0.96. The retension times of the different formulations were also similar. The results indicate that the varying viscosity grades of HPMC in combination with other auxiliaries can improve the drug release and dissolution profile. The optimum formulations demonstrated acceptable release behavior and the results of in vitro analysis were in good agreement with the theoretical models.

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