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3.0 Research Envisaged

This document outlines the research plan to develop floating microspheres for the sustained release of Dexrabeprazole sodium to treat gastric ulcers. The objectives are to formulate microspheres using different grades of HPMC polymer and study the effect on drug release through in vitro dissolution testing. The plan includes preformulation studies like drug characterization, solubility and compatibility tests. Floating microspheres will then be prepared and evaluated for yield, loading efficiency, particle size, swelling index, floating lag time and in vitro drug release. The results will be statistically analyzed to study the release kinetics and optimize the formulation for sustained delivery of Dexrabeprazole sodium.

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Aditya Jain
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70 views3 pages

3.0 Research Envisaged

This document outlines the research plan to develop floating microspheres for the sustained release of Dexrabeprazole sodium to treat gastric ulcers. The objectives are to formulate microspheres using different grades of HPMC polymer and study the effect on drug release through in vitro dissolution testing. The plan includes preformulation studies like drug characterization, solubility and compatibility tests. Floating microspheres will then be prepared and evaluated for yield, loading efficiency, particle size, swelling index, floating lag time and in vitro drug release. The results will be statistically analyzed to study the release kinetics and optimize the formulation for sustained delivery of Dexrabeprazole sodium.

Uploaded by

Aditya Jain
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as RTF, PDF, TXT or read online on Scribd
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RESEARCH ENVISAGED & PLAN OF WORK

3. RESEARCH ENVISAGED & PLAN OF WORK

3.1 Research envisaged

Aim of the present study was “Formulation, Development and Charactrization of


Floating Microspheres of Dexrabeprazole sodium the Treatment of Peptical Ulcer”.

Dexrabeprazole sodium is used to treat gastroesophageal reflux disease (GERD), a


condition in which backward flow of acid from the stomach causes heartburn and
possible injury of the esophagus (the tube between the throat and stomach).
Dexrabeprazole sodium is used to treat the symptoms of GERD, allow the
esophagus to heal, and prevent further damage to the esophagus. Dexrabeprazole
sodium is also used to decrease the chance that people who are taking nonsteroidal
anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the
stomach or intestine). It is also used with other medications to treat and prevent the
return of stomach ulcers caused by a certain type of bacteria (H. pylori).
Dexrabeprazole sodium is also used to treat conditions in which the stomach
produces too much acid such as Zollinger-Ellison syndrome. Dexrabeprazole
sodium is in a class of medications called proton pump inhibitors. It works by
decreasing the amount of acid made in the stomach.

The objective of the present study is to formulate sustained release formulation of


Dexrabeprazole sodium to study effect of polymer viscosity, polymer ratios and the
effect of diluents on the pattern of drug release by in vitro dissolution testing and to
compare it with theoretical release profile.

Preparation of sustained release formulation by matrix technique is commonly


employed method because of ease of preparation, flexibility and cost efficiency.

In this investigation we propose

1) To formulate sustained release floating microspheres using excipients like


different grade of hydroxy propyl methyl cellulose (HPMC) for optimum
delivery of Dexrabeprazole sodium.

2) To evaluate the tablet for pre- compression characteristics and tabletting

Page 1
RESEARCH ENVISAGED & PLAN OF WORK

characteristics.

3) To perform in-vitro dissolution studies.

4) The data will be subjected to statistical analysis and kinetics of release shall
be studied and reported.

3.2 Rationale of study

 The basic rationale for controlled drug delivery is to alter pharmacokinetic and
pharmacodynamic of pharmacologically active moieties by using novel drug
delivery systems or by modified the molecular structure and /or physiological
parameters inherent in a selected route of administration.

 These cover a wide range of prolonged action formulation which provide


continuous release of their active ingredient at a pre determined rate and
predetermine time, reduced side effects, etc.

 Drug having a short elimination half life, less frequent administration and better
patient compliance may be obtained with sustained release preparation as
compared to conventional dosage form.

3.3 Plan of work

A. Procurement of drug samples and excipients

Dexrabeprazole sodium (Bioplus Life Science, Bangalore, India), Ethyl


cellulose, HPMC (Mapromax, Life sciences Pvt. Ltd., Dehradun). All the
chemicals were of analytical grade.

B. Preformulation study

1. Analytical characterization of the drug


2. Solubility study
3. Compatibility study
C. Formulatilon Devlopment
Optimization of formulation of floating microspheres

5. Evaluation of floating microspheres

Page 2
RESEARCH ENVISAGED & PLAN OF WORK

 Percentage yields
 Loading efficiency and encapsulation efficiency
 Particle size analysis
 Scanning electron microscope analysis
 Determination of particle size and distribution of floating microspheres
 Swelling Index of floating microspheres
 Lag-time and floating time determination of floating microspheres
 Dissolution rates of the floating microspheres
 Zeta Potential of floating microspheres

 In-vitro release studies

Page 3

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