|
Studies on the Physico-Chemical Interaction of Ranitidine with Excipients
|
|
| Author:
|
NEHA RAUT, MILIND JANRAO UMEKAR, NANDKISHOR KOTAGALE
|
| Abstract:
|
The objective of the present study was to evaluate the compatibility of the ranitidine, a histamine H2-receptor antagonist, with pharmaceutical excipients of common use including antioxidant, solvent/binders, superdisintegrant and glidant. RNH and its blends of 1:1 ratio with butylated hydroxytoluene, polyethylene glycol 6000, sodium starch glycolate and talc were stored at 25 ± 3 0C, 2 – 8 0C and accelerated conditions of 50 ± 2 0C, 40 ± 2 0C/75 ± 5 % RH for 3 months. The physical alterations were studied by visual observations as well as by microscopy; moisture gain was determined by weight changes and spectral changes observed with UV spectrophotometer. The physico-chemical properties and compatibilities of above excipients with ranitidine were evaluated using Differential thermal analysis and Differential scanning calorimetry to determine variations in peak temperatures and/or their associated enthalpy for drug/excipient combinations to analyze existence of interaction, if any. Thermal analysis was supplemented using Fourier Transform Infrared Spectroscopy to confirm the chemical interaction. Comparison of the thermoanalytical profiles of the mixtures with individual compounds gives an evidence of physico-chemical interaction, suggests incompatibility of above excipients at accelerated conditions.
|
| Keyword:
|
Ranitidine, Butylated hydroxytoluene, Polyethylene glycol 6000, Sodiumstarchglycolate, Talc, Interaction, Incompatibility
|
| EOI:
|
-
|
| DOI:
|
-
|
| Download:
|
Request For Article
|
|
|