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May 15, 2017
Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.
May 02, 2017
Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.
April 18, 2017
In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.
April 04, 2017
Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.
April 02, 2017
Design of experiment plays a crucial role in the optimization process of formulation development.
Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
April 01, 2017
Solid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.
A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.
March 30, 2017
The newly installed Harro Hӧfliger encapsulation unit expands Capsugel’s clinical- and commercial-scale capacity for dry powder inhalation projects.
March 02, 2017
Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.