EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

FORMULATION AND ASSESSMENT COMBINATION OF SUSTAINED-RELEASE LOSARTAN POTASSIUM AND IMMEDIATE-RELEASE HYDROCHLOROTHIAZIDE

Bimal Debbarma* and Chandra Kishore Tyagi

ABSTRACT

The present study was aimed to develop bilayer tablets of Losartan potassium as Immediate Release layer and hydrochlorothiazide as Sustain Release layer to treat hypertension in type II diabetic patients. Hypertension is also one of the complications of type II Diabetes. The bilayer tablets were formulated to reduce the polytherapy to monotherapy, thus improving patient compliance. The tablets were formulated using hydrophilic polymers such as HPMC K4M and HPMC K100M in varying ratios to retard the drug release for a period of 10 hours. The immediate release layer of Losartan Potassium was formulated using Sodium Starch Glycolate (2% and 4%). The Drug-excipient interaction was investigated with FTIR spectroscopy. The study indicated that there was no interaction between the drugs and the excipients used in the formulations.The tablets were formulated by wet granulation technique because of the poor flowproperty of the drugs and blends. The formulated granules were evaluated for precompression studies which showed that the flow property was good. The formulated tablets were found to be within the limits with respect to uniformity of weight, hardness, thickness, diameter and friability. The disintegration time of Immediate Release tablets containing SSG 4% was found to be optimum. The drug content of the formulated Immediate Release tablets and Sustain Release tablets was found to be within the limits. The drug content of the bilayer tablets were estimated by simultaneous estimation method and it was found to be within the Pharmacopoeial limits. The in vitro dissolution study of the optimized bilayer tablets containing HPMC K4M and HPMC K100M in the 1:1 ratio retarded the release and met the IP specifications. The release kinetics of the optimized tablets showed that it follows first order release kinetics. The release of the drug from the matrix layer was depending on diffusion, swelling and erosion of the polymer. The stability studies indicated that the bilayer tablets were stable and do not show any significant changes in the physical characteristics, drug content and dissolution. The results obtained were found to be within the limits.

Keywords: Losartan potassium, Hydrochlorothiazide, Ethyl cellulose, Microcrystalline cellulose, Lactose, Starch, Sodium starch glycolate.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database