Excipient compatibili

ty studyPresented byRina parveen HFirst M.PharmDept of pharmaceutics

Introduction

The INTERNATIONAL PHAMACEUTICAL EXCIPIENTS COUNCIL (IPEC) have defined a pharmaceutical excipient as

“Any substances other than the active drug or prodrug which has been appropriately evaluated for safety and it is included in a drug delivery

system to either Aid processing of the system during manufacture or Protect support or enhance the stability, bioavailability, or patient acceptability orAssist in product identification orEnhance any other atttribute of the overall safety and efffectiveness of the drug product during storage or use “

When conducting the compatibility studies there are different steps to consider Sample preparation Thermal analysis X – ray diffraction studyTest for hygroscopicityMicroscopic analysisFine particle characterization analysisPowder analysisSolubility analysisStability analysisSpectroscopic analysis

Known incompatibilities of some functional group

Sl.No Functional group

Incompatibilities

Types of reaction

1 Primary amine Mono & disaccharides

Amine aldehyde &amine acetal

2 Ester ,cyclic, lactone

Basic components Ring opening ester base hydrolysis

3 Carbonyl,hydroxyl

Silanol Hydrogen bonding

4 Carboxyl Bases Salt formation

5 Alcohol Oxygen Oxidation of aldehyde &ketones

6 Sylph hydryl Oxygen Dimerization

7 Phenol Metals Complexation

8 Gelatin capsule shell

Cationic surfactant

denaturation

Fine particle characterization analysisParticle size and shape

Microscopic techniqueSieving technique

Sedimentation techniqueCoulter counter technique (electrical method