OBJECTIVES -FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF STAVUDINE

 

OBJECTIVES

          The objective of present research work was to optimize, formulate and evaluate different formulations of Sustained release matrix tablets of stavudine by using polymer HPMC.

i.       Overcome bioavailability problems.

ii.     To reduce dose dependent side- effects.

iii.  To reduce dosing frequency of administration, especially in the elderly.

iv.   Patient compliance can be improved, and drug administration can be made more convenient as well.

 

The present work was an attempt:

1.     To develop Sustained release matrix tablets contains Stavudine by using special excipient like  HPMC, EC and Magnesium stearate.

2.     To evaluate for the pre-compression characteristics of powder mixture like bulk density, flow property, angle of repose, compressibility index etc.

3.     To evaluate the post-compression characteristics of the tablet like hardness, friability, disintegration time, dispersion time, wetting time and water absorption ratio etc.

4.     To carry out in vitro dissolution studies of the tablet formulations.

5.     To carry out stability studies according to ICH guidelines.

 

PLAN OF WORK

METHOD OF COLLECTION OF DATA:

1.     The selected drug was characterized and evaluated for its physicochemical properties like solubility and compatibility with excipients.

2.     To identify the suitable excipients alone or in combine for further processing.

3.     To carry out pre-formulation studies like organoleptic properties, Bulk density, tapped density, Angle of repose, Compressibility index of the powder mixture (drug and excipients).

4.     To formulate various formulations of the drug containing different ratio of the polymer or in combination.

5.     To evaluate the compressed tablet for hardness, friability, disintegration time, In-vitro dispersion time, wetting time and In-vitro dissolution time, etc.

6.     The optimized formulation will be subjected to stability studies according to ICH guidelines.

7.     The data so obtained will be subjected for statistical analysis.

8.     The selected drug shall be characterized and evaluated for its physicochemical properties like solubility and compatibility with excipients.

9.     To identify the suitable excipients alone or in combine for further processing.

10.                        To carry out pre-formulation studies like organoleptic properties, Bulk density, tapped density, Angle of repose, Compressibility index of the powder mixture (drug and excipients).

11.                        To formulate various formulations of the drug containing different ratio of the hydrophilic polymer or in combination.

12.                        To evaluate the compressed tablet for hardness, friability, disintegration time, In-vitro dispersion time, wetting time and In-vitro dissolution time, etc.

13.                        The optimized formulation will be subjected to stability studies according to ICH guidelines.

14.                        The data so obtained will be subjected for statistical analysis.

 

The preliminary data required for the experimental study was obtained from

1.     CD-Rom search available at National Center for Scientific Information (NCSI), Indian institute of Sciences (IISc), Bangalore.

2.     Journals,

3.     Analytical chemistry Books ,

4.     Library,

5.     Relevant Books,

6.     Internet Sources ,

7.     Scientific abstracts.