Drug Development

It has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.

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.

The security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. Companies in Europe must comply with 21 CFR Part 11 if they sell in the US. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records. In particular, the record change must not obscure previously recorded information.

The aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.

Dry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.

The European Union is attempting to reform its current business environment in hopes of restoring its role in the lobal R&D sector.

In this study, the authors investigated the compression behavior of excipients with different molecular weights using the modified Fraser-Suzuki function and correlated the S-parameter of this function with Young's modulus.

The benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the computational abilities have increased the accuracy of scientific data and allowed previously difficult or impossible analytical techniques to become routine affairs. This, in turn, has led to huge advances in drug discovery and in the chemical, biochemical and physical analysis of drugs and patients.

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.