The USP Apparatus 3 is a compendial dissolution Apparatus that has been mainly used to assess the performance of modified-release drug products. However, this Apparatus can be applied to dissolution testing of immediate-release tablets as well, with several advantages such as lower consumption of dissolution media, reduced setup time in quality control routine, and minimized hydrodynamic issues. In this work, three immediate-release (IR) tablets containing antihypertensive drugs of different Biopharmaceutic Classification System (BCS) classes were evaluated in order to assess the possible interchangeability between the official dissolution method using typical USP Apparatus 1 or 2 and the proposed methods using USP Apparatus 3. Depending on the selection of the appropriate operational conditions, such as dip rate and sieve mesh size, it was observed that USP Apparatus 3 could provide similar dissolution profiles compared to USP Apparatus 1 or 2 to the drug products tested. In addition, USP Apparatus 3 avoided conning issues related to USP Apparatus 2. The successful application of USP Apparatus 3 in dissolution tests for IR drug products depends on the definition of specific test conditions for each product, considering all the equipment variables, as well as drug and formulation characteristics.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1208/s12249-018-1086-0 | DOI Listing |
J Control Release
January 2025
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Oxycodone hydrochloride (HCl) extended release (ER) tablet is an abuse-deterrent formulation that uses a physical barrier to make it more difficult to crush tablets prior to abuse via various routes. A previously conducted in vivo pharmacokinetics (PK) study showed that particle size exhibited significant effects on PK. Here, a computational modeling study using a novel combined computational fluid dynamics and physiologically based PK model was applied to better understand the mechanisms that produce differences in PK according to particle size and formulation type for nasally insufflated oxycodone HCl immediate release (IR) and ER tablets.
View Article and Find Full Text PDFJ Endod
December 2024
Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, São Paulo, Brazil. Electronic address:
Introduction: This study aimed to evaluate, using microcomputed tomography, the impact of various mechanized systems on the geometry of the root canal system and dentin thickness in mandibular first molars. The hypothesis proposed that different systems would produce significant variations in root canal system preparation.
Methods: Mesial and distal canals of mandibular molars were selected and divided into 5 groups (n = 10) based on the system used: 2Shape (25.
IEEE Open J Eng Med Biol
November 2024
Biomechatronics Laboratory, Department of Mechatronics and Mechanical SystemsEscola Politécnica da Universidade de São Paulo (USP) São Paulo 05508-010 Brazil.
The experimental study of the stumble phenomena is essential to develop novel technological solutions to limit harmful effects in at-risk populations. A versatile platform to deliver realistic and unanticipated tripping perturbations, controllable in their strength and timing, would be beneficial for this field of study. We built a modular tripping-eliciting system based on multiple compliant trip blocks that deliver unanticipated tripping perturbations.
View Article and Find Full Text PDFAAPS PharmSciTech
December 2024
Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing, 210009, China.
A slight variation in in vivo exposure for tacrolimus extended-release (ER) capsules, which have a narrow therapeutic index (NTI), significantly affects the pharmacodynamics of the drug. Generic drug bioequivalence (BE) standards are stricter, necessitating accurate assessment of the rate and extent of drug release. Therefore, an in vitro dissolution method with high in vivo predictive power is crucial for developing generic drugs.
View Article and Find Full Text PDFDiscov Nano
December 2024
Brazilian Agricultural Research Corporation, Embrapa Instrumentation, São Carlos, SP, 13561-206, Brazil.
Essential oils (EOs) are volatile compounds that may have antimicrobial and antioxidant properties. Despite their potential application, low water solubility and chemical instability are limiting factors. Nanoencapsulation processes can overcome this problem, protecting against external factors and promoting a moderate release.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!