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Polymorph Screens

Preformulation | Read Case Study

Polymorphs are examples of single compounds which, although chemically identical, exist in two or more different crystalline structures. The presence of single or multiple polymorphs can present both drug substance and drug product issues. Differences in physical and chemical properties of drug substance can impact bioavailability, dissolution rate, oral absorption, pharmacokinetics, ease of manufacturing and dosage form stability.

Salt Selection

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Salt formation can enhance solubility and dissolution rate of basic and acidic drugs, therefore improving their bioavailability and absorption. As such, salt selection should be viewed as a part of the overall strategy in choosing the optimal form of the drug substance for development.

Early Accelerated Stability Studies

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Some drug substances are sensitive to the presence of water vapor or moisture. When a drug substance interacts with moisture, the water is retained by either bulk or surface adsorption. Moisture absorption can affect the stability of the drug substance depending on how strongly the water is bounded, this depends on if the water is in a free or bound state. Moisture can also cause a salt form to break down or disassociate leaving to undesirable properties and stability concerns.


Considerations in the Development of Controlled Release Formulations

By Paul Skultety, Vice President, Pharmaceutical Services- Xcelience August 2015

Clinical Blinded Blister Cards

How to Create Multi-Fill Blister Cards Using Product Placement Shields© and UV Reactive Inks by Joseph Iacobucci – Vice President Clinical Supplies, Xcelience