Drug Development

Fridrun Podczeck is professor of pharmaceutics at Sunderland School of Pharmacy, University of Sunderland, UK

Jittima Chatchawalsaisin is a lecturer at the faculty of pharmaceutical sciences, Chalalangkom University, Bangkok, Thailand

Articles

The process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.

The Preparation of Spherical Granules by Extrusion/Spheronization without Microcrystalline Cellulose

Ranga Velagaleti is the manager of laboratory and stability at BASF Corporation, 8800 Line Ave., Shreveport, LA 71106, tel. 318.861.8040, fax 318.861.8004, velagar1@basf-corp.com

The results of forced degradation studies indicate the need for alternatives to valerophenone as an internal standard calibration for quantifying ibuprofen in bulk drug and tablet assay samples.

Photosensitivity of Internal Standard Valerophenone Used in USP Ibuprofen Bulk Drug and Tablet Assay and Its Effect on the Quantitation of Ibuprofen and Its Impurities

Ashish A. Joshi, PhD, is a project coordinator at Roquette America Inc., 1417 Exchange Street, Keokuk, IA 52632, tel. 319.526.2219, ashish.joshi@roquette.com

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques.

Added Functionality Excipients: An Answer to Challenging Formulations

Lyn Hughes, PhD, is a global technical service manager for healthcare in the Process Solutions Groups at Rohm and Haas Company, Spring House Technical Center, 727 Norristown Road, Spring House, PA 19477-0904, tel. 215.641.7329, fax 215.619.1608, lhughes@rohmhaas.com

Some of the common problems faced by formulators and how using ion exchange resins may be able to solve them are discussed.

Ion Exchange Resins Unique Solutions to Formulation Problems

Gerad Bolhuis, PhD, is as associate professor in the Department of Pharmaceutical Technology at the University of Groningen in Groningen, The Netherlands.

Recent advances in spray-drying technology have led to the production of new directly compressible lactose grades with distinct advantages.

New Developments in Spray-Dried Lactose

Charles A. Signorino, PhD, is president of CS Associates, Inc., 600 Markley Street, Norristown, PA 19401, tel. 610.279.7450, fax 610.292.9722.

Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets.

The Use of Acrylic Resins for Improved Aqueous Enteric Coating

The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.

An LC Method for the Separation and Determination of Ethynodiol Diacetate and Ethinyl Estradiol in Tablets

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.

Excipient Functionality

Dry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.

Selecting Lactose for a Capsule-Based Dry Powder Inhaler

Pharmacist and professor of biopharmacy, Biopharmaceutics Department

Pascale Gauthier is a pharmacist and directs courses for the Biopharmaceutics Department, Faculty of Pharmacy

Previous articles have presented a general review of the different types of spheres that can be obtained with a rotary fluidized bed process.1,2 This two-part study focusses on lipid spheres that can be prepared using hydrogenated castor oil, as well as examining the feasibility of the process and the main characteristics of the spheres obtained.

Ingredients