Application of In Vitro Release Methods to Assure Product Performance of Semisolid Dosage Forms Before and After Certain Post-Approval Changes

Shah, Vinod P.; Elkins, Jerome; Schuirman, Donald; Pelsor, Francis R.; Shrlvastava, Surendra; DeCamp, Wilson; Schwartz, Paul; Williams, R. O.

doi:10.14227/dt050398p5

Dissolution Technol.

1998

DOI: 10.14227/dt050398p5

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Application of In Vitro Release Methods to Assure Product Performance of Semisolid Dosage Forms Before and After Certain Post-Approval Changes

Vinod P. Shah¹,

Jerome Elkins²,

Donald Schuirman³

et al.

Abstract: The key paramete r for any drug product is its efficacy as demonstrated in controlled clinic.,.] trials. The time and expense associated with such trials make t11em unsui table as ro utiJle quality control merl,ods. Therefore, in vitro surrogate tests are often used to assure th at product quality

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The relevance of polymeric synthetic membranes in topical formulation assessment and drug diffusion study

Rouse

Sanderson

et al. 2012

Arch. Pharm. Res.

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Synthetic membranes are composed of thin sheets of polymeric macromolecules that can control the passage of components through them. Generally, synthetic membranes used in drug diffusion studies have one of two functions: skin simulation or quality control. Synthetic membranes for skin simulation, such as the silicone-based membranes polydimethylsiloxane and Carbosil, are generally hydrophobic and rate limiting, imitating the stratum corneum. In contrast, synthetic membranes for quality control, such as cellulose esters and polysulfone, are required to act as a support rather than a barrier. These synthetic membranes also often contain pores; hence, they are called porous membranes. The significance of Franz diffusion studies and synthetic membranes in quality control studies involves an understanding of the fundamentals of synthetic membranes. This article provides a general overview of synthetic membranes, including a brief background of the history and the common applications of synthetic membranes. This review then explores the types of synthetic membranes, the transport mechanisms across them, and their relevance in choosing a synthetic membrane in Franz diffusion cell studies for formulation assessment purposes.

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The relevance of polymeric synthetic membranes in topical formulation assessment and drug diffusion study

Rouse

Sanderson

et al. 2012

Arch. Pharm. Res.

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Formulation and optimisation of Ozenoxacin topical nano-emulgel including a comprehensive methodology to qualify and validate the critical parameters of an in-vitro release test method and ex-vivo permeation test

Ramireddy,

Behara

2024

Drug Development and Industrial Pharmacy

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Drug release from semisolid dosage forms: a comparison of two testing methods

Petró

Paál

Erös

et al. 2013

Pharmaceutical Development and Technology

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The aim of the present work was to extend our previous in-vitro drug release studies using semisolid dermatological bases with non-impregnated cellulose acetate membranes. A comparison of the performances of two apparatuses, the more commonly used Franz cell and the new modified USP (mini paddle with ointment holding cell) systems were applied to this work. Five different semisolid as well as two marketed preparations containing 1% diclofenac sodium were used. Complex, slightly non-linear release curves indicating sink conditions were found. This was explained by the co-diffusion of excipients modifying the characteristics of the membrane and the receiving medium dynamically. Although our test model is, as a rule, not suitable to establish an in-vivo-in-vitro correlation, good qualitative as well as quantitative correlations were found within some types of dermatological bases. The correlation between the results of the two in-vitro methods also depends on the type of semisolids studied. The release curve characteristics and the amount of diclofenac sodium released at 6 h were measured. Their repeatability and reproducibility were calculated. The slopes and Q-values were correlated with in-vivo data. In general, the modified USP method provided more precise results than the Franz cell method.

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Application of In Vitro Release Methods to Assure Product Performance of Semisolid Dosage Forms Before and After Certain Post-Approval Changes

Cited by 3 publications

References 0 publications

The relevance of polymeric synthetic membranes in topical formulation assessment and drug diffusion study

The relevance of polymeric synthetic membranes in topical formulation assessment and drug diffusion study

Formulation and optimisation of Ozenoxacin topical nano-emulgel including a comprehensive methodology to qualify and validate the critical parameters of an in-vitro release test method and ex-vivo permeation test

Drug release from semisolid dosage forms: a comparison of two testing methods

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