Preformulation Excipient Compatibility Testing. Application of a Differential Scanning Cal0Rimetric Method Versus a Wei Granulation Simulating, Isothermal Stress Method

Chrzanowski, Frank A.; Ulissi, Lucy A.; Fegely, B. J.; Newman, Azarine C.

doi:10.3109/03639048609048037

Cited by 23 publications

(3 citation statements)

References 7 publications

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“…The use of differential scanning calorimetric analysis has also been described for this purpose (8,9). This method offers the advantage of being able to dispense with storage.…”

Section: Evalution Of Exrerimentsmentioning

confidence: 98%

Preformulation the Role of Moisture in Solid Dosage Forms

Schepky¹

1989

Drug Development and Industrial Pharmacy

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Moisture plays an important role in the individual stages of preformulation studies for solid dosage forms. Examples are given to demonstrate this. active substance using a reliable storage scheme. Then compatibility testing between active and inactive substances is performed. Under the general heading of sorption tests, the determination of sorption isotherms using special apparatus and their correlation with the physical and chemical changes which occur in the samples are discussed. With the results of these tests it is often possible to influence the sorption properties of the finished dosage form, for example by selection of the excipients and the salt form of the active substance, or by deferring the point of ansorption.Finally, as an example of special tests used in preformulation, the development of compound preparations is described and the galenical pre-stages are discussed.The first stage involves chemical tests with the pure 1715 Copyright 0 1989 by Marcel Dekker, Inc. Drug Dev Ind Pharm Downloaded from informahealthcare.com by QUT Queensland University of Tech on 11/01/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by QUT Queensland University of Tech on 11/01/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by QUT Queensland University of Tech on 11/01/14 For personal use only.

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“…The use of differential scanning calorimetric analysis has also been described for this purpose (8,9). This method offers the advantage of being able to dispense with storage.…”

Section: Evalution Of Exrerimentsmentioning

confidence: 98%

Preformulation the Role of Moisture in Solid Dosage Forms

Schepky¹

1989

Drug Development and Industrial Pharmacy

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“…Thermal methods such as differential thermal analysis (DTA) or differential scanning calorimetry (DSC) are welldeveloped techniques for the detection of incompatibility in drug-excipient mixture [4][5][6]. Since the thermal analysis used is relatively fast, easily interpreted, accurately predictive, and requires only a few test samples, it has been suggested in many studies for the routine screening of potential drugexcipient interactions in preformulation stability testing [7][8][9][10]. …”

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confidence: 99%

Compatibility problems of chlorpromazine HCl-stearate lubricants examined by differential scanning calorimetry

Lin¹,

Kao²

1990

Journal of Thermal Analysis

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Differential scanning calorimetry (DSC) was used to investigate the interactions between chlorpromazine HC1 (CPZ) and stearate lubricants. The phase diagram was constructed for each CPZ-stearate system. An unknown endothermic peak at 145~ was found for the CPZstearate lubricants; this was affected by the grinding and heating processes. This unknown endothermic peak proved to relate to a polymorphism transition but was not an incompatibility problem. Three polymorphisms of CPZ were also determined by DSC analysis and IR spectrophotometry.It is well known that drug-excipient interactions can exert significant influences on the physico-chemical properties, manufacture and bioavailability of a solid dosage form [1][2][3]. Drug-excipient compatibility testing is a practically reliable preformulation tool to select appropriate excipients for each dosage form design. Thermal methods such as differential thermal analysis (DTA) or differential scanning calorimetry (DSC) are welldeveloped techniques for the detection of incompatibility in drug-excipient mixture [4][5][6]. Since the thermal analysis used is relatively fast, easily interpreted, accurately predictive, and requires only a few test samples, it has been suggested in many studies for the routine screening of potential drugexcipient interactions in preformulation stability testing [7][8][9][10].

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“…Outras abordagens simulam o estresse ocasionado pelos processos de fabricação, tais como a granulação via úmida, submetendo as misturas binárias à umidificação e secagem ou à compressão, pela formação de pastilhas por meio de prensas. Tais procedimentos visam a melhor previsão das interações pela maior similaridade com as condições encontradas na manipulação (CHRZANOWSKI et al, 1986).…”

Section: Introductionunclassified

Caracterização no estado sólido dos polimorfos de tibolona

Araújo¹

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Às minhas mãezinhas, Francisca Ferreira Costa, Maria das Graças Lima Barros e Dona Ruth (in memorian) Ao meu tio, Jair da Costa Aos meus sogros, Maria Helena do Lago Takano e Edison Takano Ao meu pai, Hamilton José de Araujo (in memorian)por doarem seu amor e parte da vida para me ajudar a ser feliz e alcançar meus sonhos. ABSTRACTTibolone is a synthetic steroid widely used in hormone replacement therapy in

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Preformulation Excipient Compatibility Testing. Application of a Differential Scanning Cal0Rimetric Method Versus a Wei Granulation Simulating, Isothermal Stress Method

Cited by 23 publications

References 7 publications

Preformulation the Role of Moisture in Solid Dosage Forms

Preformulation the Role of Moisture in Solid Dosage Forms

Compatibility problems of chlorpromazine HCl-stearate lubricants examined by differential scanning calorimetry

Caracterização no estado sólido dos polimorfos de tibolona

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