Pharmaceutical Quality Management
The behavior of aged soft gelatin based hematinic capsules may be attributed to gelatin- mineral and gelatin – vitamin interactions reflected subsequently in the non-compliance with the official disintegration test standards as seen from their rupture/ dissolution time. Both these terms refer to these properties associated with the shell. This article evaluates gelatin- mineral interaction based on a case study I did during my postgraduate days for a well-known company. To make the scientific community abreast of the research findings with out divulging or any way comprising confidentiality with the company or anybody else associated with the work, I have extracted the relevant details for community learning.
The work was initiated after conducting an exhaustive literature survey. Glimpses from some of the prior art is presented here. Ludwig and Ooteghem (1979 and 1980) report on the mechanism of disintegration of hard gelatin capsules.
Ridgeway (1987) described the chemistry and reactions of gelatin. Cooper et al (1972) investigated liquid and solid solution interactions of primary certified colorants with pharmaceutical gelatin. The author used ultraviolet (UV) and attenuated total reflectance (ATR) infrared spectroscopy for evaluating this film. Bhalla and Lalla (1990) and Chowhan et al (1985 and 1986) employed thermal analysis for evaluating drug-excipient compatibility.
Drug migration into the soft gelatin shells and its influence on (1) in vitro availability of the drugs has been reported by Amstrong et al (1983) and Berry (19893) respectively. However, there are no literature reports on the bioavailability of minerals / vitamins from fresh and stored hematinic soft gelatin capsules. An observation that the soft gelatin based hematinic failed to comply with the Indian Pharmacopoeia disintegration test after storage led us (1993) to study the reasons for this behavior, because of the large-scale use of hematinic capsules in soft gelatin shells all over the world.