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A winning combination: The benefits of micronization and containment in a single installation

Pharmaceutical Technology

This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.

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PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

XTalks

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Epidiolex contains sesame seed oil, restricting its use for some individuals.

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Expert Insights: Development and Manufacture of Highly Potent Oral Liquids

XTalks

Best practices include the use of contained engineering solutions to safeguard drug product integrity and protect operators. Improved bioavailability can lead to a faster onset of therapeutic effects, which is especially valuable in conditions where prompt action is required.

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports. Where Are the Technical Rejection Criteria for Study Data Applied? Validation Code.

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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

Given our expertise in the provision of IVMT studies to investigate the absolute bioavailability of oral drug molecules, we have developed a particular focus in recent years on the conduct of integrated IVMT/ADME studies. What makes Quotient Sciences’ approach to these study types unique?