Results 261 to 270 of about 1,965,906 (302)
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Dissolution Profiles for Capsules and Tablets Using a Magnetic Basket Dissolution Apparatus
Journal of Pharmaceutical Sciences, 1972Dissolution studies were carried out on commercially available dosage forms of lithium carbonate, 300 mg. A magnetic basket dissolution apparatus was developed by the authors because of the unavailability of a single system to evaluate both capsules and tablets.
R E, Shepherd, J C, Price, L A, Luzzi
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Journal of Pharmaceutical and Biomedical Analysis, 1998
Dissolution efficiency (D.E.), the area under a dissolution curve between defined time points, and the fit factors (f1 and f2) have been compared for the characterisation of dissolution profiles, using data from three batches of a product in nine different packs stored under two conditions.
N H, Anderson +5 more
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Dissolution efficiency (D.E.), the area under a dissolution curve between defined time points, and the fit factors (f1 and f2) have been compared for the characterisation of dissolution profiles, using data from three batches of a product in nine different packs stored under two conditions.
N H, Anderson +5 more
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Statistical modeling approaches for the comparison of dissolution profiles
Pharmaceutical Statistics, 2022AbstractDissolution studies are a fundamental component of pharmaceutical drug development, yet many studies rely upon the and model‐independent approach that is not capable of accounting for uncertainty in parameter estimation when comparing dissolution profiles.
Tony Pourmohamad, Hon Keung Tony Ng
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Dissolution Profiles of Ceftizoxime Suppository
Drug Development and Industrial Pharmacy, 1993AbstractThe in vitro dissolution rates of ceftizoxime suppository were compared using a rotating dialysis cell method, a dialysis membrane method and the JP XI rotating basket method. Only small variations in the dissolution rates were found with the rotating dialysis cell method and the rotating basket method, while the dialysis membrane method ...
Sotoo Asakura +2 more
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Methods to Compare Dissolution Profiles
Drug Information Journal, 1996The objective of this work was to apply several profile comparison approaches to dissolution data of four different Metoprolol tartrate tablet formulations in order to quantify each method's metric for comparing dissolution profiles. Dissolution was performed using the United States Pharmacopeia (USP) monograph method on four formulations of metoprolol
James E. Polli +2 more
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Journal of Pharmaceutical Negative Results, 2012
Purpose: Entacapone, a catechol-O-methyltransferase inhibitor, is poorly water soluble (BCS class IV). The dissolution profile of pure Entacapone is improved in the presence of an alkaline buffer and after addition of a surfactant by facilitating the drug release process at the solid/liquid interface. Rationale: According to USP the best dissolution
TA Premchandani, SK Pallewar, AM Pethe
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Purpose: Entacapone, a catechol-O-methyltransferase inhibitor, is poorly water soluble (BCS class IV). The dissolution profile of pure Entacapone is improved in the presence of an alkaline buffer and after addition of a surfactant by facilitating the drug release process at the solid/liquid interface. Rationale: According to USP the best dissolution
TA Premchandani, SK Pallewar, AM Pethe
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Dissolution Profiles for Finely Divided Drug Suspensions
Journal of Pharmaceutical Sciences, 1983A suspension of micronized prednisolone acetate was separated into four fractions by the technique of centrifugal elutriation. Data showed that each fraction had a narrow particle size. The dissolution experiments were carried out under sink conditions (less than 10% of saturation concentration) in a dissolution apparatus with a rotating filter ...
John W. Mauger +3 more
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Comparison of Dissolution Profiles: A Statistician’s Perspective
Therapeutic Innovation & Regulatory Science, 2018Dissolution profile comparisons are used in the context of postapproval changes where the manufacturer has to demonstrate that the quality of the product is not affected by the change. Around this topic, basic statistical principles are in conflict with widely used interpretations of current guidelines, resulting in time-intensive discussions in ...
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Therapeutic Innovation & Regulatory Science, 2021
The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use M9 Guidelines for Biopharmaceutics Classification System Biowaivers reached harmonization in November 2019. However, guidelines for bioequivalence studies are not internationally harmonized, and water as a dissolution medium ...
Eiji Kajiwara +2 more
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The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use M9 Guidelines for Biopharmaceutics Classification System Biowaivers reached harmonization in November 2019. However, guidelines for bioequivalence studies are not internationally harmonized, and water as a dissolution medium ...
Eiji Kajiwara +2 more
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Dissolution Profiles of Flurbiprofen in Phospholipid Solid Dispersions
Drug Development and Industrial Pharmacy, 1998This study is concerned with the development of a solid dispersion formulation of flurbiprofen (FLP) and phospholipid (PL) with improved dissolution characteristics. The FLP powders were blended with PL to produce FLP-PL physical mixtures or made into solid dispersions with PL by the solvent method.
M J, Habib, M T, Phan, G, Owusu-Ababio
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