ArticleMolecular pharmaceutics2023
Impact of Gastric pH Variations on the Release of Amorphous Solid Dispersion Formulations Containing a Weakly Basic Drug and Enteric Polymers.
Article in Molecular pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed, 46 citations in OpenAlex.
- Engineering Oral Nanoparticles: Navigating Biological Barriers in the Gastrointestinal Tract.Pharmaceutical research · 2026Review
- Advances in veterinary drug and vaccine delivery: from conventional delivery methods to innovative transdermal approaches.Drug delivery and translational research · 2026Review
- Sustained-release enteric formulations of Lactiplantibacillus plantarum based on granulation technology: preparation and therapeutic evaluation in acute colitis.BMC biotechnology · 2026Article
- Process Optimisation, Pharmaceutical Characterisation, and in vitro Activity of Mesalamine Nanocrystals in PMA-differentiated THP-1 cell Lines in the Late Inflammatory and Profibrotic Phase.AAPS PharmSciTech · 2026Article
- Proton Nuclear Magnetic Resonance Relaxation in Aqueous Sugar Solutions: Can Low-Field Nuclear Magnetic Resonance Relaxation Measurements Differentiate between "Bound" and "Free" Water?ACS physical chemistry Au · 2026Article
- Amorphous Solid Dispersions for BCS Class II Antihyperlipidemic Drugs: From Drug-Polymer Interactions to in vivo Performance.Drug design, development and therapy · 2026Review
- Enteric Coating Enhances the Biopharmaceutical Performance of a Silica-Lipid Formulation of Abiraterone Acetate.Pharmaceutics · 2025Article
- Review
- Development of 3D-Printed Two-Compartment Capsular Devices for Pulsatile Release of Peptide and Permeation Enhancer.Pharmaceutical research · 2024Article
- Amorphous Solid Dispersion Formation for Enhanced Release Performance of Racemic and Enantiopure Praziquantel.Molecular pharmaceutics · 2024Article
- Vibriocidal efficacy of Bifidobacterium bifidum and Lactobacillus acidophilus cell-free supernatants encapsulated in chitosan nanoparticles against multi-drug resistant Vibrio cholerae O1 El Tor.BMC infectious diseases · 2024Article
- Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023.International journal of pharmaceutics: X · 2024Article
- HPMCAS-Based Amorphous Solid Dispersions in Clinic: A Review on Manufacturing Techniques (Hot Melt Extrusion and Spray Drying), Marketed Products and Patents.Materials (Basel, Switzerland) · 2023Review
- Emerging Applications of Hydroxypropyl Methylcellulose Acetate Succinate: Different Aspects in Drug Delivery and Its Commercial Potential.AAPS PharmSciTech · 2023Review
- Enteric coating of tablets containing an amorphous solid dispersion of an enteric polymer and a weakly basic drug: A strategy to enhance in vitro release.International journal of pharmaceutics · 2023Article
- Advances in the development of amorphous solid dispersions: The role of polymeric carriers.Asian journal of pharmaceutical sciences · 2023Review
- Fed- and Fasted-State Performance of Pretomanid Amorphous Solid Dispersions Formulated with an Enteric Polymer.Molecular pharmaceutics · 2023Article
- Super Bioavailable (SUBA) Itraconazole-Induced Galactorrhea-Could it be due to Hydroxypropyl Methylcellulose Phthalate?Indian dermatology online journalArticle
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Enteric polymers are widely used in amorphous solid dispersion (ASD) formulations. The aim of the current study was to explore ASD failure mechanisms across a wide range of pH conditions that mimic in vivo gastric compartment variations where enteric polymers such as hydroxypropyl methylcellulose phthalate (HPMCP) and hydroxypropyl methylcellulose acetate succinate (HPMCAS) are largely insoluble. Delamanid (DLM), a weakly basic drug used to treat tuberculosis, was selected as the model compound. Both DLM free base and the edisylate salt were formulated with HPMCP, while DLM edisylate ASDs were also prepared with different grades of HPMCAS. Two-stage release testing was conducted with the gastric stage pH varied between pH 1.6 and 5.0, prior to transfer to intestinal conditions of pH 6.5. ASD particles were collected following suspension in the gastric compartment and evaluated using X-ray powder diffraction and scanning electron microscopy. Additional samples were also evaluated with polarized light microscopy. In general, ASDs with HPMCP showed improved overall release for all testing conditions, relative to ASDs with HPMCAS. ASDs with the edisylate salt likewise outperformed those with DLM free base. Impaired release for certain formulations at intestinal pH conditions was attributed to surface drug crystallization that initiated during suspension in the gastric compartment where the polymer is insoluble; crystallization appeared more extensive for HPMCAS ASDs. These findings suggest that gastric pH variations should be evaluated for ASD formulations containing weakly basic drugs and enteric polymers.
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