TopProvider LB - Pharmaceutical Manufacturing Reso
TopProvider LB - Pharmaceutical Manufacturing Reso

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A Comprehensive Approach for Solid Form Selection in Preclinical Development and Beyond.

A Comprehensive Approach for Solid Form Selection in Preclinical Development and Beyond.

Different solid forms (polymorphs, salts, cocrystals) of an active pharmaceutical ingredient (API) can have very different physico-chemical properties. Those...

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Rapid Development of an Amorphous Solid Dispersion (ASD) – Nifedipine (NIF)

Rapid Development of an Amorphous Solid Dispersion (ASD) – Nifedipine (NIF)

Amorphous solid dispersions (ASD) have long been used to increase the solubility and bi-oavailability of poorly-soluble compounds. A considerable amount of...

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Microcrystal Electron Diffraction Study of Multi-component Salt and Cocrystal Forms of 3-Nitrobenzoic Acid and Pyrimethanil

Microcrystal Electron Diffraction Study of Multi-component Salt and Cocrystal Forms of 3-Nitrobenzoic Acid and Pyrimethanil

Three single-phase crystals containing 3-nitrobenzoic acid (NBA) and pyrimethanil (PYR) in a 1:1 stoichiometry were found, and their structures were...

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Utility of Low Frequency (LF) Raman Mapping: Dissolution of Acetaminophen (ACE) Spray Dried Dispersions (SDD)

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...

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Cocrystals: A Regulatory Rebirth

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...

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In situ observation of Theophylline anhy-drous forms II, III, V, and I* using Variable-Temperature, Variable-Relative Humidity Powder X-ray Diffraction

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...

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Novel Non-Crystalline Materials Analysis: New Strategies to De-risk Amorphous Material Formulation D

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...

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Application of Low-Frequency (LF) Raman Spectroscopy to an Isoenergetic Polymorph Study

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...

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