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Abstract

FORMULATION, DEVELOPMENT AND INVITRO EVALUATION OF PINDOLOL (PDL) SUPPOSITORY FOR THE TREATMENT OF HYPERTENSION

Farheen Naaz*, Dr. Syed Abdul Azeez Basha, Tahani

ABSTRACT

Pindolol(PDL) is a non selective moderately lipophillic beta – blocker (adrenergic beta-antagonists). Chemically it is [2-hydroxy-3-(1Hindol- 4-yloxy) propyl](propan-2-yl)amine. It is non-cardioselective and has intrinsic sympathomimetic actions, but little membranestabilizing activity. The purpose of this study was to develop an immediate release rectal suppositories. Different formulation of 20mg Pindolol were prepared as immediate release rectal suppositories by fusion method PEG 4000, PEG 6000 and Polaxomer188 are hydophillic bases used as standard excipients for formulation of Pindolol (PDL)suppository. Cross carmallose sodium(CCS) was used as super disintegrant with a view to improve bioavailability.The prepared suppositories were evaluated for visual characteristion, hardness, thickness, friability, melting point, Weight variation, Disintegration time, Content uniformity, In-vitro drug release. The drug release profiles were studied in phosphate buffer PH 7.4.The optimized formulation of Pindolol suppository containing different ratios of hydrophilic base(PEG 4000) and superdisintegrant (Cross carmallose sodium) was found to be having no interactions upon FT-IR analysis. Differential scanning colorimetry characterization of optimized formulation showed respective peaks at different temperature revealing the compatibility of the drug and hydrophillics bases formulated with the superdisintegrant. Visual characterisation revealed that any fissuring, pitting, fat bloom, exudation and migration of active ingredients were not found in any of the formulation from F1-F9. All the formulations were found to be within limits. Invitro drug release studies showed that among all formulations, F5 formulation was considered as optimised formulation as it showed 99.14% of drug release within 180 mins. The data obtained in the in vitro drug release studies were fitted into various kinetic equations like Zero order, first order Higuchi, Korrs- meyer peppas equation. The kinetic data shows the values were best fitted to Higuchi model. Stability studies as per ICH guidelines on promising prepared suppository indicated that there are no significant changes in physical characterization and drug release patterns.

Keywords: Pindolol(PDL), PEG 4000, PEG 6000, Polaxome188r, Cross carmallose sodium(ccs), Suppositories, melting time, in vitro residence.


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