A Discriminating Dissolution Method for Glimepiride Polymorphs

Bonfílio, Rudy; Pires, Sumaia Araújo; Ferreira, Leonardo Miziara Barboza; Almeida, Adélia Emília de; Araújo, Magali Benjamim; Salgado, Hérida Regina Nunes

doi:10.1002/jps.22799

Cited by 30 publications

(21 citation statements)

References 26 publications

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“…9 exhibit multiple distinct peaks, indicating their crystalline nature. Mannitol characteristic peaks correspond to beta D mannitol (CSD DMANTL11), whereas glimepiride (CSD TOHBUN01) main peaks (13.52, 18.23, 21.18) correspond to polymorph I (Bonfilio et al, 2012;Nagpal et al, 2012). Glimepiride diffraction peaks disappear in PVA filament and 3D printed dosage form, indicating the conversion of the API to an amorphous dispersion inside the polymer matrix.…”

Section: Resultsmentioning

confidence: 99%

A 3D printed bilayer oral solid dosage form combining metformin for prolonged and glimepiride for immediate drug delivery

Gioumouxouzis

Baklavaridis

Katsamenis

et al. 2018

European Journal of Pharmaceutical Sciences

169

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Section: Resultsmentioning

confidence: 99%

A 3D printed bilayer oral solid dosage form combining metformin for prolonged and glimepiride for immediate drug delivery

Gioumouxouzis

Baklavaridis

Katsamenis

et al. 2018

European Journal of Pharmaceutical Sciences

169

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“…Dissolution testing has been a key tool during drug development stages and in the commercial preparation of the dosage forms (3,5). At the formulation development stage, dissolution testing is used to evaluate stability, monitor product consistency, and assess the effect of variables (e.g., changes in formulation and process parameters) on the characteristics of the final product (6). For commercial products, dissolution testing is used to confirm manufacturing and product consistency and to evaluate process variables (7).…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone

Khan¹

2017

Dissolution Technol.

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• Disintegration controlled absorption: The APIs have better solubility profiles, and the resultant dosage forms show higher dissolution rates. Dissolution rate of a drug can be enhanced by increasing its disintegration. Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone Amjad KhanDepartment of Pharmacy, Abasyn University, Peshawar-25120, Pakistan ABSTRACTThe orally disintegrating tablet (ODT) is a novel dosage form that disintegrates in the oral cavity using saliva as the disintegrating medium and is swallowed as a fine dispersion. Due to rapid disintegration, the dissolution rate is controlled by the intrinsic solubility of the API; therefore, it is difficult to evaluate the effect of formulation and processing parameters on in vitro drug release. Thus, a dissolution method that can discriminate among in vitro release profiles of ODTs with varying natures is needed. The objective of the present study was to develop and validate a discriminative dissolution testing method for ODTs of domperidone. Different experimental conditions such as dissolution medium composition, dissolution medium volume, and paddle rotation speed were evaluated. Analysis of dissolution samples was carried out by HPLC using a combination of water at pH 3 and acetonitrile (65:35 v/v) as the mobile phase. The developed dissolution method was validated according to ICH guidelines for various parameters such as specificity, accuracy, precision, and stability. The discriminatory nature of the method was confirmed by determining the dissolution rate of ODTs containing pulverized and unpulverized domperidone. The best in vitro dissolution profile was obtained using purified water containing 1% Tween 80 as the dissolution medium (900 mL) stirred at 50 rpm. Complete dissolution (100.09 ± 0.37%) was achieved within 60 min, and the dissolution medium did not interfere with sample analysis. All the validation parameters were in an acceptable range (RSD > 2%). A comparison of the dissolution profiles in official and developed media showed significant differences based on f 1 and f 2 values. The developed dissolution test exhibited a higher capacity than the compendial methods in differentiating the release profiles of ODTs. It can be applied during formulation development and quality control analysis of ODTs for evaluation of the effects of formulation and processing parameters.

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“…Assim, observa-se um grande número de publicações nesta área por parte do meio acadêmico. [1][2][3][4][5][6] Muitas publicações têm sido realizadas por grupos brasileiros ou com participação de seus pesquisadores, [7][8][9][10][11][12] sendo a contribuição nacional para o tema razoavelmente relevante. Recentemente, um artigo de revisão foi publicado, 13 com a perspectiva de divulgar um texto que p opo io asseà ate ialà deà estudoà i t odut ioàaosài i ia tesà oàte a .àMes oà sendo um material de excelente qualidade, algumas considerações também interessantes e que podem nortear o trabalho de quem começa a caminhar nas alvoradas da cristalinidade de fármacos não foram abordadas em tal artigo.…”

Section: Introductionunclassified

Solid State in the Pharmaceutical Industry: A Brief Review

Prado¹,

Rocha²

2015

Revista Virtual De Química

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Abstract:Most marketed pharmaceuticals consist of molecular crystals due to reasons of stability and ease handling during the development. Pharmaceutical solids can exist in the different forms. The arrangement of the molecules in a crystal determines its physical properties, influences the formulation, as well as dissolution rate and stability. Several examples are reported to demonstrate the importance of polymorphism in properties that can change the quality of the final product. A thorough understanding of the relationships between physical structures and the properties of pharmaceutical solids is therefore important in selecting the most suitable form. In this review, the different crystal forms of pharmaceuticals, the commonly used solid-state analytical techniques and advantages and disadvantages of each technique are discussed. In more detail, here is exposed the impact of solid forms in a galenic level.Keywords: Polymorphism; drug; analytical techniques; bioavailability; stability; processability. ResumoMuitos fármacos comercializados consistem em cristais moleculares devido a razões de estabilidade e para facilitar o manuseio durante o desenvolvimento. Sólidos farmacêuticos podem existir em diferentes formas. O arranjo das moléculas no cristal determina as suas propriedades físicas, influencia a formulação, assim como a taxa de dissolução e estabilidade. Diversos exemplos são relatados para demonstrar a importância do impacto do polimorfismo em propriedades que podem alterar a qualidade do produto final. Uma compreensão completa das relações entre as estruturas físicas e as propriedades dos sólidos farmacêuticos é, portanto, importante na escolha da forma mais apropriada. Nesta revisão, as diferentes formas cristalinas de fármacos, as técnicas de análise de estado sólido comumente utilizadas e as vantagens e desvantagens de cada técnica são discutidas. De forma mais detalhada é exposto o impacto das formas sólidas em nível galênico.

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A Discriminating Dissolution Method for Glimepiride Polymorphs

Cited by 30 publications

References 26 publications

A 3D printed bilayer oral solid dosage form combining metformin for prolonged and glimepiride for immediate drug delivery

A 3D printed bilayer oral solid dosage form combining metformin for prolonged and glimepiride for immediate drug delivery

Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone

Solid State in the Pharmaceutical Industry: A Brief Review

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