fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Shah, Vinod P.; Lesko, Lawrence J.; Fan, Jim; Fleischer, Nicholas M.; Handerson, James; Malinowski, H.; Makary, Moheb H.; Ouderkirk, Larry; Roy, Suva; Sathe, Pradeep; Singh, Gulab; Tillman, Lloyd; Tsong, Yi; Williams, Roger L.

doi:10.14227/dt040497p15

Cited by 76 publications

(31 citation statements)

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“…13 However, it was found that drug was getting precipitated in HCl buffer pH 1.2 and acetate buffer pH 4.6, therefore, 2.2% w/v SLS was added to both the buffers. The saturation solubility of aprepitant was observed to increase over pure drug in all the vehicles used.…”

Section: Saturation Solubilitymentioning

confidence: 99%

Preparation and Characterization of Nanosuspension of Aprepitant by H96 Process

S¹,

Deshpande²,

Attari³

et al. 2016

Adv Pharm Bull

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Section: Saturation Solubilitymentioning

confidence: 99%

Preparation and Characterization of Nanosuspension of Aprepitant by H96 Process

S¹,

Deshpande²,

Attari³

et al. 2016

Adv Pharm Bull

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“…The release profiles of the untreated and elastase‐treated microparticles from all formulations were compared for similarity using the Fit Factor, f 2 , described by Moore and Flanner [17] . This test has also been adopted by the US Food and Drug administration for comparison of the dissolution profiles of immediate release solid oral dosage forms [18] . In this test, the average dissolution value from each time point for each formulation was compared and the overall similarity was calculated.…”

Section: Methodsmentioning

confidence: 99%

Inhalable, bioresponsive microparticles for targeted drug delivery in the lungs

Sivadas

Cryan

2011

Journal of Pharmacy and Pharmacology

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Objective There is a growing interest in developing bioresponsive drug delivery systems to achieve greater control over drug release than can be achieved with the conventional diffusion controlled polymeric delivery systems. While a number of such systems have been studied for oral or parenteral delivery, little or no work has been done on bioresponsive delivery systems for inhalation. Using the raised elastase levels present at sites of lung inflammation as a proof‐of‐concept model, we endeavoured to develop a prototype of inhalable elastase sensitive microparticles (ESMs). Methods Microparticles degradable by the enzyme elastase were formed by crosslinking the polymer alginate in the presence of an elastase substrate, elastin, using Ca+2 ions and subsequent spray drying. Key findings The bioresponsive release of a protein cargo in the presence of elastase demonstrated the enzyme‐specific degradability of the particles. The microparticles showed favorable properties such as high drug encapsulation and good powder dispersibility. Potential polymer toxicity in the lungs was assessed by impinging the microparticles on Calu‐3 cell monolayers and assessing changes in transepithelial permeability and induction of cytokine release. The microparticles displayed no toxic or immunogenic effects. Conclusions With a manufacturing method that is amenable to scale‐up, the ability to be aerosolised efficiently from a first‐generation inhaler device, enzyme‐specific degradability and lack of toxicity, the ESMs show significant promise as pulmonary drug carriers.

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“…Drug release tests were carried out according to conventional dissolution procedures recommended for single-entity products [24][25][26], using basket (USP Apparatus 1) at 75 and 100 rpm ( Table 1). Sampling aliquots of 5.0 mL were withdrawn at 0, 5, 10, 15, 30 and 60 minutes, and replaced with an equal volume of the fresh medium to maintain a constant total volume.…”

Section: Dissolution Test Conditionsmentioning

confidence: 99%

Development and Validation of a Dissolution Method with Spectrophotometric Analysis for Diacerhein Capsules

Borgmann¹,

Parcianello²,

Arend³

et al. 2008

Sci Pharm

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The aim of this work was to develop and validate a dissolution test for diacerhein in capsules using spectrophotometric method. The dissolution established conditions were: 900 mL of sodium phosphate buffer pH 7.0 with 0.75 % of sodium lauryl sulphate as dissolution medium, using a basket apparatus at a stirring rate of 50 rpm. The drug release was evaluated by UV spectrophotometric method at 258 nm. The method was validated to meet requirements for a global regulatory filing. The validation included specificity, linearity, precision and accuracy. In addition, filter suitability and drug stability in medium were demonstrated. The comparison of the obtained dissolution profiles of capsules, obtained from three different brands (denominate product A, B and C) of 50 mg diacerhein, was performed and the results showed no significative difference among the products.

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fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Cited by 76 publications

References 0 publications

Preparation and Characterization of Nanosuspension of Aprepitant by H96 Process

Preparation and Characterization of Nanosuspension of Aprepitant by H96 Process

Inhalable, bioresponsive microparticles for targeted drug delivery in the lungs

Development and Validation of a Dissolution Method with Spectrophotometric Analysis for Diacerhein Capsules

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