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Pharmaceutical Technology: Controlled Drug Release, Volume 2

Pharmaceutical Technology: Controlled Drug Release, Volume 2

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92 CH. 8] TOPICAL RELEASE AND PERMEATION STUDIES<br />

Table 1—Formulations<br />

a Formulation A was also made at 0.5%, 2% and 3% concentration of drug.<br />

stability of drug was determined in the buffer solution. After 24 h at 37°C no potency loss was<br />

noted.<br />

Content uniformity<br />

All samples prepared were analysed for propranolol hydrochloride content. Only samples with<br />

100% ±10% drug contents were used in these studies.<br />

IN VITRO DIFFUSION STUDIES<br />

The in vitro diffusion studies for each sample were carried out by using the Franz diffusion cells<br />

with a diffusional area of about 1.76cm 2 . The acceptor compartment of the apparatus was filled<br />

with the buffer solution pH 6, USP [21], and maintained at 37±0.5°C via a circulating water<br />

system. The diffusion membrane (the cellulose membrane with a molecular weight cut-off point<br />

of 1000 or the hairless mouse skin) previously prepared was placed between the donor and the<br />

acceptor compartments of the assembly. An accurately weighed 4g of sample was then placed in<br />

the donor cell and the diffusion process was started. The solution in the acceptor compartment<br />

was continuously stirred with a small magnetic stirrer to maintain the sink conditions. Aliquots<br />

from the receptor cells were removed at 0.5, 2, 4, 8 and 24 h time intervals and replaced with equal

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