Quick Menu

Upcoming Journals

Journal of Pharmaceutical Research International

Journal of Pharmaceutical Research International, ISSN: 2456-9119, ISSN: 2231-2919 (past),Vol.: 20, Issue.: 1

 

Original-research-article

 

Design and Evaluation of a New Fixed-Dose Immediate Release Capsule of Atenolol, Enalapril Maleate and Hydrochlorothiazide

 

 

Nickania A. Pryce1, Amusa S. Adebayo2*, Deon A. Bennett3 and Eugenie Brown-Myrie1

1Department of Pharmaceutics, School of Pharmacy, College of Health Sciences, University of Technology, Jamaica, 237 Old Hope Road, Kingston 6, Jamaica.

2Department of Biopharmaceutical Sciences, School of Pharmacy, Roosevelt University, Chicago, Illinois, USA.

3Department of Chemistry, Faculty of Science and Sports, University of Technology, Jamaica, 237 Old Hope Road, Kingston 6, Jamaica.

 

Abstracts

 

Aim and Objectives: To design, formulate and perform in vitro studies of a fixed dose combination (FDC) immediate release solid dosage form of the antihypertensive drugs atenolol, enalapril and hydrochlorothiazide. The objectives of the study were to perform pre-formulation studies, design an immediate-release FDC capsule dosage form, and evaluate the prepared dosage form.

Methods: Differential Scanning Calorimetric (DSC) analysis of physical mixtures of drugs and drug-excipient combinations was used to assess compatibility. Binary mixtures of atenolol and enalapril form a eutectic mixture indicating that a tablet dosage form, in which the drugs would be highly compressed together, may not be stable. Hard gelatin shell encapsulation was therefore employed. Atenolol and enalapril were separately dry-granulated with hydrochlorothiazide and excipients and mixed together at appropriate therapeutic proportions and encapsulated in size 1 hard gelatin capsules (HGC). Preliminary screening produced five formulations each with similar proportions of the 3-drug FDC but with 5 different levels of disintegrant. Capsule weight variation, disintegration time and dissolution rate were determined as output variables, following USP procedures. For the dissolution studies, a reverse phase high-pressure liquid chromatographic (RP-HPLC) method was developed for simultaneous analysis of the three drugs.

Results: Granules possessed good fluidity (compressibility index 8.53 to 11.63 and tapped bulk density 1.09 to 1.132). Capsule disintegration time was generally £ 2 minutes while 80% of each drug dissolved within 20 minutes. Capsules showed no sign of physical instability or adverse effect during a period of 1 year shelf storage at room temperature (average temperature 25°C).

Conclusions: Granules possess adequate fluidity and compressibility for filling into HGC. Results generally indicated that an immediate release FDC capsule of atenolol, enalapril and hydrochlorothiazide was stable for more than 1 year of observation. Capsule disintegration time and dissolution rate were generally within the USP specification.

 

Keywords :

Atenolol; enalapril; hydrochlorothiazide; fixed-dose combination; eutectic mixture.

 

Full Article - PDF    Page 1-16    Article Metrics

 

DOI : 10.9734/JPRI/2017/38019

Review History    Comments

Search this site

Advanced Search

Announcement & News

ISI Thomson Reuters selected British Journal of Pharmaceutical Research for Emerging Sources Citation Index

We are delighted to inform that ISI Thomson Reuters selected British Journal of Pharmaceutical Resea...

SCOPUS selected Annual Research & Review in Biology (ARRB)

We are delighted to inform that famous indexing organization SCOPUS (from Elsevier) selected  A...

Index Copernicus Evaluation Result Released

We are delighted to inform that Index Copernicus (a leading indexing organization from Pol...

Journal Repository (JR): Permanent Digital Archiving of SDI journals

SDI is happy to announce that all our journals are now permanently archived in Journal Repository (J...

Index Copernicus Value of British Journal of Medicine and Medical Research

  We are delighted to inform that Index Copernicus (a leading indexing organization ...

SDI journal got 35th ranking in Publons

We are delighted to announce (as of 04/01/2016) that British Journal of Medicine and Medical Re...

Growth of SDI and world publication market

As of 2014, total 25,064 journals are competing in World market of journal publication. In 2011, tot...

Publication and site statistics (up to Sept, 2015)

  Number of submission: 22181 (Total up to Sept, 2015) Number of published paper: 10949&n...

Index Medicus selected 15 SDI journals

We are delighted to inform that Index Medicus (IMSEAR) has selected following 15 SDI journals for in...

SCIENCEDOMAIN international received 5844 submissions in 2013

SCIENCEDOMAIN international is pleased to announce that it has received 5844 submissions in 2013, ac...



SCIENCEDOMAIN Awards

  • No Awards listed.

Browser Compatibility : Mozila firefox, Google Crome and IE 7 & above. Creative Commons License Terms & Condition   |   Privacy Policy   |   Join Us   |   Help   |   Contact Us
© Copyright 2010-2017, SCIENCEDOMAIN international. All rights reserved.