Dissolution Profiles for Finely Divided Drug Suspensions

Mauger, John W.; Howard, Stephen A.; Amin, Kirit

doi:10.1002/jps.2600720225

Cited by 14 publications

(3 citation statements)

References 3 publications

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“…That could only be achieved using another value of k. The best fit (quantified by the mean residue, R h , and maximum residue, R max 29 ) gave a value k ) 0.28 ( Figure 7), which corresponds to a value of h that is approximately half of the particle radius. Values of k different from 0.5 were also reported by Mauger et al 13 for the dissolution of particles of prednisolone acetate. It should be outlined, however, that the exact value of k is normally unknown.…”

Section: Resultssupporting

confidence: 67%

Modeling Dissolution of Sparingly Soluble Multisized Powders

Almeida¹,

Simões²,

Brito

et al. 1997

Journal of Pharmaceutical Sciences

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0 The dissolution of powder drugs, besides being a topic of utmost importance, especially for the sparingly soluble ones, is far from being well-explained. The purpose of the present study is, on the one hand, to obtain experimental dissolution profiles and, on the other hand, to analyze and process the data for dissolution modeling. Three different size fractions of a widely used sparingly soluble drugsibuprofenswere fully characterized with regard to its particle size distribution, specific surface area, density, solubility, and diffusion coefficient. The dissolution profiles were obtained making use of a technique that counts and sizes particlessthe Coulter counter techniqueswhich is capable of following the number and size of the particles in suspension throughout time. The knowledge of these parameters allowed a critical study of the assumptions associated with the models currently used to describe the dissolution process. It was concluded that most of the assumptions were not valid for the present experimental conditions. This motivated the proposal of a new methodology, which uses the experimentally determined characteristics of the drug and takes into account the polydisperse nature of the powder. By applying an adequate dissolution equation to each of the many size classes in which the primary particle size distribution was divided, it was possible to obtain a large agreement between the simulated and the experimental dissolution profile.

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Section: Resultssupporting

confidence: 67%

Modeling Dissolution of Sparingly Soluble Multisized Powders

Almeida¹,

Simões²,

Brito

et al. 1997

Journal of Pharmaceutical Sciences

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show abstract

“…This model was also con®rmed by Mauger et al 10 in their study of micronized prednisolone acetate dissolution.…”

Section: Introductionmentioning

confidence: 61%

General solution for diffusion‐controlled dissolution of spherical particles. 2. Evaluation of experimental data

Wang

Flanagan

2002

Journal of Pharmaceutical Sciences

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“…Algumas suspensões possuem materiais que tendem a aglomerar, o que faz com que a área de superfície seja significativamente menor que aquela medida nas partículas primárias (Bisrat, 1988). De qualquer forma, o tamanho da partícula tem uma importância fundamental também na dissolução de suspensões (Bates, 1969;Mauger, 1983;Bisrat, 1988). Já foi demonstrado experimentalmente que partículas muito pequenas (micronizadas) apresentam, além de uma área de superfície maior, uma camada de difusão menos espessa, o que resulta num transporte mais rápido de moléculas dissolvidas a partir da superfície para o meio de dissolução (Bisrat, 1988).…”

Section: Suspensõesunclassified

Dissolução de medicamentos: fundamentos, aplicações, aspectos regulatórios e perspectivas na área farmacêutica.

Marcolongo¹

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Dissolution testing is a very important tool in the pharmaceutical industry, so much in development as in routine quality control. Although it was first developed for solid dosage forms, in the last years it has been used for nonsolid forms as suspensions, transdermal patches, suppositories and others. Recently, with the discussion concerning generics drug products, other uses for the dissolution test have become important. Dissolution profiles comparison, for instance, is essential to avoid performing bioequivalence studies in all strengths of a product. Brazilian regulation states that the dissolution profile comparison should be done using f 1 and f 2 factors, mathematical equations to establish the similarity or non-similarity between two profiles. Another important aspect concerning dissolution is the Biopharmaceutical Classification System. It divides the drugs in four categories based on solubility and permeability. It is said that class I drugs (high solubility and high permeability) could be waived from the bioequivalence study if the product shows also rapid dissolution. Brazilian regulation, following an international regulatory approach, has incorporated in the actual regulation quality aspects, including dissolution, and now quality proof is absolutely necessary for a drug product authorization.

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Dissolution Profiles for Finely Divided Drug Suspensions

Cited by 14 publications

References 3 publications

Modeling Dissolution of Sparingly Soluble Multisized Powders

Modeling Dissolution of Sparingly Soluble Multisized Powders

General solution for diffusion‐controlled dissolution of spherical particles. 2. Evaluation of experimental data

Dissolução de medicamentos: fundamentos, aplicações, aspectos regulatórios e perspectivas na área farmacêutica.

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