Ingredients

Various systems and measures can be used to safely handle and process explosive pharmaceutical compounds in a range of manufacturing procedures.

Bioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.

New Excipient Guidance Doesn?t Fill Regulatory Gap

The authors propose a strategy for classifying and validating inprocess testing methods.

The authors study the effects of sweet potato and cocoyam starches on the compressional and mechanical characteristics of a paracetamol tablet formulation using cornstarch BP.

Nanostructured lipid carriers are a new type of delivery system offering improved performance in terms of drug loading and long-term stability with the ability to form highly concentrated dispersions...

In this article, the author explains some of the technology behind using ion-exchange resins for drug delivery...

This article examines the importance of core design and formulation on the quality of a film coated tablet...

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

International Specialty Products (ISP) and Niro A/S have formed an alliance to develop and market spray drying and formulation technologies...

This article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

The authors examine the effects of three superdisintegrants on the dissolution and absorption of tenoxicam from solid-dispersion formulations.

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

With creative engineering and sophisticated chemistry, industry scientists offer big solutions for attaining small particle sizes and narrow distributions.

By enhancing stability and in vitro drug-release characteristics, limonene enantiomers are a natural-source alternative for developing and characterizing self-nanoemulsified drug delivery systems.

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 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.

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

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

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

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

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

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

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.

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.

Erythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.

The tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components (separately and with drugs) and the individual constituents. The compaction properties were also investigated. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.

Medicines and excipients are inseparable, with few exceptions - one cannot exist without the other. The Pharmaceutical Quality Group and other international bodies have developed good manufacturing practice (GMP) standards and guidelines to facilitate the effective supply of excipients. This article discusses the definition and significance of excipients, and highlights the importance of implementing the correct excipient manufacturing controls and standards.