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911, 2018

Manufacturing of Capsules Requires Formulation Adaptations

By |November 9th, 2018|Categories: Formulation Development & Clinical Trial Materials|0 Comments

APIs, excipients, capsule materials and production methods should all complement one another in order to prevent difficulties. Whether a drug formulation exists as a liquid, granule or gel, capsules can serve as a useful oral dosage form. They combine the advantages of tablets, in that they are easy for patients [...]

611, 2018

Crucial Steps For Obtaining Medical Device Regulatory Compliance

By |November 6th, 2018|Categories: Preclinical|Tags: , |0 Comments

By aligning the many interlocking parts of the design process, manufacturers can greatly increase the likelihood of regulatory approval. The invention of a medical device is only the first step in the process of determining its clinical and commercial viability. From the moment a manufacturer selects a device to develop, [...]

507, 2018

5 Key Challenges in Medical Device Preclinical Testing

By |July 5th, 2018|Categories: Preclinical|Tags: , |0 Comments

The engineering of a medical device constitutes only one aspect of its viability. In order to obtain regulatory approval, a device also needs to comply with biocompatibility and sterilization standards. Raw materials, packaging, and design may all impact a device’s safety and compatibility, and a preclinical assessment of all these [...]

1506, 2018

Preformulation

By |June 15th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

A clear understanding of a drug’s chemical properties will lead to a better formulation design. Before a formulation is developed around an active pharmaceutical ingredient (API), that API itself must be clearly understood. A careful analysis of the solubility, stability and other chemical properties of a newly discovered API will [...]

606, 2018

Clinical Trial Material Manufacturing

By |June 6th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

Logistical challenges demand close collaboration from the early stages of the development process. Some fundamental requirements apply to all clinical trial supply chains. Manufacturing facilities must comply with Good Manufacturing Practice (GMP) guidelines, including effective sterilization and cold chain management. Formulations must be screened regularly for quality, and containers must [...]

1905, 2018

Polymorph Screening

By |May 19th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|0 Comments

Advancing technologies are helping developers discover polymorphs more rapidly than ever. But production and legal issues can pose significant challenges. An active pharmaceutical ingredient (API) can take many forms. This is particularly true of solid-state compounds, whose salts can form according to an unpredictable range of structures. These crystalline structural [...]

1405, 2018

Liquid Oral Suspensions

By |May 14th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|0 Comments

These dosage forms provide key advantages over other liquids, but federal guidelines advise caution in manufacturing. The broad category of liquid oral doses includes a diverse group of dosage forms, from monophasic forms like syrups, spirits, elixirs and extracts, to biphasic forms like suspensions, emulsions and mixtures. While each of [...]

1105, 2018

Dosage Forms

By |May 11th, 2018|Categories: Uncategorized|0 Comments

Manufacturing of all dosage forms is becoming increasingly specialized, demanding expertise from developers and CMOs alike. As an active pharmaceutical ingredient (API) is developed into a formulation, the manufacturer must naturally consider how the drug will be administered. The question of dosage forms has more answers today than ever before; [...]

405, 2018

Commercial Drug Manufacturing

By |May 4th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Scaling up to the commercial stage demands strategic thinking – but it can also bring significant new opportunities. Once a viable active pharmaceutical ingredient (API) has been developed, and clinical trials have delivered promising results, the next step is to scale up the manufacturing pipeline to produce commercial-scale batches of [...]