Drug Development

Using melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.

A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

When choosing a CRO, take the time to conduct an in-depth evaluation of each department, paying special attention to the quality and training of its personnel.

Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.

Extensive research has been conducted to improve the solubility and permeability of acetazolamide in hopes that a topical formulation for the treatment of glaucoma can be developed.

A new set of proposed GMP standards for excipents may present more problems than benefits.

A global drug master file system may pave the way for faster qualifications of new excipients and the industry's acceptance of their use in drug therapies.

A knowledgeable and experienced contract service provider can help in the development and success of an inhalation drug product.

Adhesives manufacturers can be involved in the development of transdermal drug delivery products by working with pharmaceutical companies on R&D, materials qualification, manufacturing, and other product development tasks.

The authors discuss the physiocomechanical characteristics of three commonly used pharmaceutical excipients and describe the effects of variables on their physiocomechanical stability.

Poly(vinyl acetate) phthalate-based and acrylic-based enteric coating systems are evaluated for their performance on acetylsalicylic acid tablets in areas such as acid resistance and coated-tablet stability.

Two types of hydrogels used in parenteral protein-delivery systems offer opportunities for achieving a variety of prolonged- and delayed-release patterns.

Insulin is one of the most popular proteins to be studied for oral delivery. The authors review the current status of the development strategies of insulin drug delivery systems, the various challenges associated with these systems, and how these challenges may be overcome.

The author proposes a strategy for achieving a successful partnership with Big Pharma on the basis of forming a relationship with the company, deliberately managing the alliance, and clearly defining roles and responsibilities.

The author assesses the compressibility of Plasdone S- 630 copovidone-based tablet formulations using roller-compaction and direct-compression processes.

This comparative study suggests that pregelatinized starches are superior to natural starches in terms of improving the plastic deformation in tablet formulations during compression.

This study attempts to determine the combination of excipients found in commercial ASA products that would be suitable for use in an aqueous enteric film&#173coating process.

Both academia and industry have been encouraged to generate quick&#173dissolving dosage forms as the demand for fast&#173disintegrating tablets and capsules has steadily increased.

To aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.

Careful planning and decision-making can circumvent possible delays in technology transfers.

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.

Developments in technology and increased industry standards have changed the regulation, quality control, and perception of excipients in the past 25 years.

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.

Using formulations containing various types of lactose and dibasic calcium phosphate, the authors investigated the effects of lubricant level, lubrication time, and compression speed on tablet weight, hardness, and friability.

Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.