STABILITY STUDIES OF COMMERCIALLY AVAILABLE ANTACID FORMULATIONS IN POLYETHYLENE TEREPHTHALATE (PET) CONTAINERS

Muhammad Usman, Khan (1996) STABILITY STUDIES OF COMMERCIALLY AVAILABLE ANTACID FORMULATIONS IN POLYETHYLENE TEREPHTHALATE (PET) CONTAINERS. Doctoral thesis, University of the Punjab.

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Abstract

The use of plastic polymers in the pharmaceutical packaging, has grown considerably during the last two decades. Amongst the commonly used plastics, the use or polyethylene terephthalate (PET) is gaining popularity in the industrialized countries for packaging of soft drinks, edible oils, alcoholic beverages and mineral water. The present study involves the evaluation of the utilization of PET bottles .for use as pharmaceutical containers for antacid formulations. The stability study was conducted by keeping amber-coloured PET bottles containing two commercially available antacid formulations, Dijex MP and Filmacid Forte Gel, in refrigerator and at room temperature, 37°C, 45°C and 80oC. Various parameters were examined, as a function of time. The study revealed that initially viscosity and pH decreased slightly and then remained unchanged. There was no effect on the concentration of Al (OH3) and Mg (OH)2 but a decrease in the concentration of simethicone was observed. Other tests such as OTC test, ANC test and CO2 determination also remained within the offical limit. However, simethicone lost its defoaming activity at 45°C after six months and significant flavour loss was observed at elevated temperatures (37°C and 45°C). Qualitative GC analysis revealed leaching of various migrants from the container’s wall into the formulation, one of which has been identified as terephthalic acid.

Item Type: Thesis (Doctoral)
Uncontrolled Keywords: antacid formulations, plastics, polyethylene terephthalate, pet bottles, drug stability
Subjects: R Medicine > RM Therapeutics. Pharmacology
Depositing User: Muhammad Khan Khan
Date Deposited: 27 Oct 2016 04:53
Last Modified: 27 Oct 2016 04:53
URI: http://eprints.hec.gov.pk/id/eprint/2851

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