Abstract
This study aimed to evaluate and compare, using the methodology of Franz diffusion cells, the ketoprofen (KTP) releasing profiles of two formulations: A gel and a conventional suspension. The second aim was to show that this methodology might be easily applied for the development of semi-solid prototypes and claim proof in pre-formulation stages. Drug release analysis was carried out under physiological conditions (pH: 5.6 to 7.4; ionic strength 0.15 M; at 37 °C) for 24 h. Three independent vertical Franz cells were used with a nominal volume of the acceptor compartment of 125 mL and a diffusion area of 2.5 cm2. Additionally, two different membranes were evaluated: A generic type (regenerated cellulose) and a transdermal simulation type (Strat-M®). The KTP permeation profiles demonstrated that depending on the membrane type and the vehicle used, the permeation is strongly affected. High permeation efficiencies were obtained for the gel formulation, and the opposite effect was observed for the suspension formulation. Moreover, the permeation studies using Strat-M membranes represent a reproducible methodology, which is easy to implement for pre-formulation stage or performance evaluation of semi-solid pharmaceutical products for topical or transdermal administration.
Highlights
With the remarkable interest in the development of innovative pharmaceutical products worldwide, suitable methods need to be established to evaluate the fundamental physicochemical parameters required in pre-formulation studies
Because of the potential that the formulations of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) for topical use represent for the treatment of inflammatory chronic and acute conditions, we evaluate the permeation rate of a gel of KTP in semi-solid state using Franz cells simulating specific conditions of human skin
The selection of the membrane is a critical step because generic membranes such as regenerated cellulose can provide evidence on important changes associated with the size of the drug evaluated and the vehicle used to dissolve it
Summary
With the remarkable interest in the development of innovative pharmaceutical products worldwide, suitable methods need to be established to evaluate the fundamental physicochemical parameters required in pre-formulation studies. In the case of topical formulations, for which the drug is released through the skin, evaluation of the permeation is critical to establish bioavailability and thereby make an approximation of the effectiveness. Some NSAIDs commonly used in medical practice include acetylsalicylic acid, ketoprofen (KTP), ibuprofen, naproxen, indomethacin and piroxicam [9,10,11,12,13,14]. These drugs carry out their pharmacological action by decreasing inflammation, fever and pain processes
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