Effect of Material Properties and Variability of Mannitol on Tablet Formulation Development
ConclusionThe study elucidated the linkage between fundamental material attributes and mechanical properties of mannitol, highlighting their impact on tablet defects and compaction performance in compression. A comprehensive understanding of the variability in mannitol properties between vendors and lots is crucial for successful formulation development, particularly when high percentages of mannitol are included as a brittle excipient. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Challenges and Opportunities for Celecoxib Repurposing
AbstractDrug repositioning, also known as drug repurposing, reprofiling, or rediscovery, is considered to be one of the most promising strategies to accelerate the development of new original drug products. Multiple examples of successful rediscovery or therapeutic switching of old molecules that did not show clinical benefits or safety in initial trials encourage the following of the discovery of new therapeutic pathways for them. This review summarizes the efforts that have been made, mostly over the last decade, to identify new therapeutic targets for celecoxib. To achieve this goal, records gathered in MEDLINE PubMed a...
Source: Pharmaceutical Research - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Accelerating Drug Product Development and Approval: Early Development and Evaluation
(Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Drug-Polymer Miscibility and the Overlap Concentration (C*) as Measured by Rheology: Variation of Polymer Structure
ConclusionsOur findings will aid researchers in designing or selecting appropriate polymers to inhibit crystallization of poorly soluble drugs. This research also suggests thatC* as determined by rheology can be used to compare drug-polymer interactions for similar molecular weight polymers.Graphical abstract (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Revamping Biopharmaceutics-Pharmacokinetics with Scientific and Regulatory Implications for Oral Drug Absorption
ConclusionThese results place an end to the routinely reported exponential %absorbedversus time curves prevailing in biopharmaceutics-pharmacokinetics since their inception in the ’60 s. These findings point to the use of the F.A.T. concept in drug absorption research and regulatory guidelines such as deconvolution techniques for the assessment of drug input rate, stochastic mean absorption time calculations, population analyses,in vitroin vivo correlations and bioequivalence guidelines. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 3, 2023 Category: Drugs & Pharmacology Source Type: research
Solid Form Screenings in Pharmaceutical Development: a Perspective on Current Practices
AbstractSolid form screening is a crucial step in new drug development because solid forms of a drug substance significantly affect stability, dissolution and manufacturing processes of its drug products. This perspective introduces solid-state science from a practical standpoint, aiming to reduce knowledge gaps and promote communications among scientists with diverse background. This perspective starts with a concise overview that followed by discussion on timeline and goals of solid form screening. Techniques for solid from identification and characterization are then discussed. Subsequently, the perspective presents c...
Source: Pharmaceutical Research - August 3, 2023 Category: Drugs & Pharmacology Source Type: research
Revamping Biopharmaceutics-Pharmacokinetics with Scientific and Regulatory Implications for Oral Drug Absorption
ConclusionThese results place an end to the routinely reported exponential %absorbedversus time curves prevailing in biopharmaceutics-pharmacokinetics since their inception in the ’60 s. These findings point to the use of the F.A.T. concept in drug absorption research and regulatory guidelines such as deconvolution techniques for the assessment of drug input rate, stochastic mean absorption time calculations, population analyses,in vitroin vivo correlations and bioequivalence guidelines. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 3, 2023 Category: Drugs & Pharmacology Source Type: research
Solid Form Screenings in Pharmaceutical Development: a Perspective on Current Practices
AbstractSolid form screening is a crucial step in new drug development because solid forms of a drug substance significantly affect stability, dissolution and manufacturing processes of its drug products. This perspective introduces solid-state science from a practical standpoint, aiming to reduce knowledge gaps and promote communications among scientists with diverse background. This perspective starts with a concise overview that followed by discussion on timeline and goals of solid form screening. Techniques for solid from identification and characterization are then discussed. Subsequently, the perspective presents c...
Source: Pharmaceutical Research - August 3, 2023 Category: Drugs & Pharmacology Source Type: research
Evaluation of Encequidar as An Intestinal P-gp and BCRP Specific Inhibitor to Assess the Role of Intestinal P-gp and BCRP in Drug-Drug Interactions
ConclusionsECD may allow an in-depth appraisal of the role of intestinal efflux transporter(s) in drug disposition in animals and humans through local intestinal drug interactions. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
Re-visitation of Two Models for Predicting Mechanically-Induced Disordering after Cryogenic Impact Milling
ConclusionsPrediction accuracy of the ρcrit model decreased with dataset expansion, relative to previously published results. Overall, the ρcrit model was considerably less accurate relative to the bivariate empirical model, which retained very high prediction accuracy for the expanded dataset. Although the empirical model does not imply a mechanism, model robustness suggests the importance of glass transition temperature (Tg) and molar volume (Mv) on formation and persistence of amorphous materials following extensive cryomilling. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
Evaluation of Encequidar as An Intestinal P-gp and BCRP Specific Inhibitor to Assess the Role of Intestinal P-gp and BCRP in Drug-Drug Interactions
ConclusionsECD may allow an in-depth appraisal of the role of intestinal efflux transporter(s) in drug disposition in animals and humans through local intestinal drug interactions. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables
AbstractSubcutaneously administered drugs are growing in popularity for both large and small molecule drugs. However, development of these systems – particularly generics – is slowed due to a lack of formal guidance regarding preclinical testing andin vitro–in vivo correlations (IVIVC). Many of these methods, while appropriate for oral drugs, may not be optimized for the complex injection site physiologies, and release rate and absorption mechanisms of subcutaneous drugs. Current limitations for formulation design and IVIVC can be supported by implementing mechanistic, computational methods. These methods can help to...
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
Re-visitation of Two Models for Predicting Mechanically-Induced Disordering after Cryogenic Impact Milling
ConclusionsPrediction accuracy of the ρcrit model decreased with dataset expansion, relative to previously published results. Overall, the ρcrit model was considerably less accurate relative to the bivariate empirical model, which retained very high prediction accuracy for the expanded dataset. Although the empirical model does not imply a mechanism, model robustness suggests the importance of glass transition temperature (Tg) and molar volume (Mv) on formation and persistence of amorphous materials following extensive cryomilling. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables
AbstractSubcutaneously administered drugs are growing in popularity for both large and small molecule drugs. However, development of these systems – particularly generics – is slowed due to a lack of formal guidance regarding preclinical testing andin vitro–in vivo correlations (IVIVC). Many of these methods, while appropriate for oral drugs, may not be optimized for the complex injection site physiologies, and release rate and absorption mechanisms of subcutaneous drugs. Current limitations for formulation design and IVIVC can be supported by implementing mechanistic, computational methods. These methods can help to...
Source: Pharmaceutical Research - July 31, 2023 Category: Drugs & Pharmacology Source Type: research
Coformer-Dependent Physical Stability in a Series of Naringenin-Based Coamorphous Materials with Caffeine, Theophylline, and Theobromine
ConclusionFive naringenin-based multi-component solids were generated in this study: 3 new CAMs, 1 new cocrystal, and 1 previously reported cocrystal. Destabilization of CAMs was found to be exposure specific and coformer dependent. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 28, 2023 Category: Drugs & Pharmacology Source Type: research
