Content by Triclinic Labs, Inc
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Utility of Low Frequency (LF) Raman Mapping: Dissolution of Acetaminophen (ACE) Spray Dried Dispersions (SDD)
This application note outlines the evaluation of post-dissolution ACE SDD. The results indicated that in all of the cases studied, ACE remained amorphous upon dissolution if it was intimately mixed in the dispersion. However, phase separation from the polymer allowed ACE to crystallize as... -
Cocrystals: A Regulatory Rebirth
What is the impact of recent changes in FDA guidance on regulatory and intellectual property issues? The FDA reclassification of cocrystals as active pharmaceutical ingredients (APIs) has created exciting opportunities for the pharmaceutical industry. That reclassification means cocrystals can...
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Rapid Development of an Amorphous Solid Dispersion (ASD) – Nifedipine (NIF)
Amorphous solid dispersions (ASD) have long been used to increase the solubility and bio-availability of poorly-soluble compounds. A considerable amount of research has been car-ried out and has generated useful techniques in the area of ASD development. Surprisingly, the number of examples with... -
In situ observation of Theophylline anhy-drous forms II, III, V, and I* using Variable-Temperature, Variable-Relative Humidity Powder X-ray Diffraction
Theophylline was investigated using an Anton Paar Controlled Humidity Chamber (CHC+) attachment on a Rigaku SmartLab powder diffractometer to observe polymorphic transitions as a function of temperature and relative humidity. The experiments resulted in the observa-tion of Forms II, III, V, and...
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Novel Non-Crystalline Materials Analysis: New Strategies to De-risk Amorphous Material Formulation D
The latest approaches for characterizing non-crystalline (amorphous) materials and determining physical stability under typical storage conditions. Amorphous forms consist of disordered arrangements of molecules that do not possess a distinguishable crystal lattice. Different forms of a drug... -
Application of Low-Frequency (LF) Raman Spectroscopy to an Isoenergetic Polymorph Study
The importance of polymorphism in the pharmaceutical industry is well established. Much literature exists describing the effect of polymorphs on efficacy, the phenomenon of polymorphism, and the analytical tools available to study polymorphism in active pharmaceutical ingredients and drug...
