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Abstract

FORMULATION AND IN-VITRO CHARACTERIZATION OF MULTI UNIT PARTICULATES AS RESERVOIR SYSTEMS USING HYDROPHOBIC POLYMERS

Dr. M. Sunitha Reddy*, Md. Ameeroddin, Muhammad S. Fazal Ul Huq and Dr. V. Venkateswarlu

ABSTRACT

The aim of the present study is to formulate and optimize a suitable composition of Multi Unit Particulates (MUPs) as reservoir systems using hydrophobic polymers and achieve the pH independent drug release. Various drugs belonging to BCS Class – I and II have been scrutinized and Propranolol.HCl was found to be suitable for the study based on its availability. In the current study, the pellets are formulated as the reservoir units. The objective of formulating the reservoir systems is to increase the mean residence time of the dosage form in GIT and to enhance the bioavailability of the drugs. The Multi MUPs of Propranolol.HCl have been prepared using different hydrophobic polymers like PVA (KOLLICOAT®), Ethyl Cellulose (ETHOCEL STANDARD PREMIUM) (10cps, 20cps, and 100cps) in varied proportions. The initial evaluations prioritized the use of a pore former and so HPMC (HYPROMELLOSE 6cps) and PEG 400 were used. Multiple layering techniques were found preferable to the single layering technique with an enhanced and reproducible drug release profiles with that of RLD (Inderal® LA). The suitable composition of the polymer, plasticizer and pore former were optimized. The formulated MUPs have been subjected to evaluation tests which include Fill weight determination, Weight variation, Locked length analysis, Disintegration Time, Assay, Dissolution, Uniformity of dosage units, Related substances, Residual solvents, Water content and Alcohol dose dumping studies. From the evaluation studies it was found that formulation (F6) (by multiple layering technique) consisting of Ethyl cellulose 20cps, Dibutyl sebacate, PEG® 400 in 70:10:20 ratios (w/w) was optimum. The in – vitro dissolution studies showed a drug release of 98.5 ± 1.8%. Results of Accelerated stability studies showed that formulation was stable and does not alter the drug release.

Keywords: Multi Unit Particulates (MUPs), reservoir systems, hydrophobic polymers, controlled release, multiple layering technique, evaluations.


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