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

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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

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 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

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