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Design of pH-independent controlled release matrix tablets for acidic drugs.
Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility
In this review paper, excipient impurity classes are categorized into six major classes, including reducing sugars, aldehydes, peroxides, metals, nitrate/nitrite, and organic acids, and the potential reactions with drug candidates of these impurities are reviewed.
Controlled and complete release of a model poorly water-soluble drug, prednisolone, from hydroxypropyl methylcellulose matrix tablets using (SBE)(7m)-beta-cyclodextrin as a solubilizing agent.
This work shows that incorporation of (SBE)(7M)-beta-CD into the matrix tablets could be considered in designing a sustained-release tablet of poorly water-soluble drugs.
Formation of reactive impurities in aqueous and neat polyethylene glycol 400 and effects of antioxidants and oxidation inducers.
- J. Hemenway, Thiago C. Carvalho, S. Varia
- ChemistryJournal of pharmaceutical sciences
- 1 September 2012
Antioxidantsbutylated hydroxyanisole, butylated hydroxytoluene, propyl gallate d-alpha tocopheryl polyethylene glycol-1000 succinate, and sodium metabisulfite were effective in limiting reactive impurity formation, whereas ascorbic acid and acetic acid were not.
When can cyclodextrins be considered for solubilization purposes?
The cyclodextrin utility number, U(CD), a dimensionless number, is introduced to assess the feasibility of the use of CDs in dosage forms and was been extended to ionizable drugs that show synergistic increase in solubility due to ionization and complexation.
Effect of Sodium Lauryl Sulfate in Dissolution Media on Dissolution of Hard Gelatin Capsule Shells
SLS interacts with gelatin to form a less-soluble precipitate at pH < 5.5, and the use of SLS in dissolution media at acidic pH should be carefully evaluated for gelatin capsule products.
Co-solubilization of poorly soluble drugs by micellization and complexation.
Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity…
This article summarizes Sessions 1 and 2 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products and addresses of predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms.
Effect of force feeder on tablet strength during compression.
The Pharmaceutical Use of Captisol®: Some Surprising Observations
It appears that there is an initial resistance to fluid flow from the tablet through the rate-limiting microporous membrane that decreases so that even as osmotic pressure and concentration differences drop with time, counterbalancing faster release occurs.