Dosage Forms

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.

Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

Consideration of the key process variable will define the ease with which coating processes can be transferred from development to production. This study investigates those factors influencing atomization from two spray guns and examines how development-scale procedures on interchangeable drum coating equipment compare with those typically used in a production environment.

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 author offers a primer for choosing the correct granulation process to improve yields, reduce tablet defects, and enhance productivity.

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.

High quality tablet compression tooling is expensive, albeit consumable. With the potential for tooling damage during tablet production, transportation and storage, an acceptable method of cleaning, repairing, validating and storing tooling is required by anyone who manufactures tablets - and the regulatory inspection authorities.

Decision-making tools such as expert systems and artificial neural networks can be integrated to facilitate the development of optimal formulations of hard gelatin capsules.

Spreadability of a semisolid forrmulation is affected by factors such as formulation characteristics, rate and time of shear, temperature, site of application, and the presence of various additives.

Dynamic powder-sampling methods may be the best techniques for obtaining a representative sample for determining particle-size distribution.

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.

Recent advances in polymer science have resulted in a wide range of commercially available polymers for use in transdermal drug delivery systems.

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

Powdered self-emulsified dosage forms provide an attractive alternative to filled-capsule preparations, but the selection of a proper excipient is crucial.

In this study, the authors examine the suitability of 0.45 &#181m&#150rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.

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.

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.

Semisolid dosage forms are advantageous in terms of their easy application, rapid formulation, and ability to topically deliver a wide variety of drug molecules.

The development of a successful powder for injection formulation requires careful study of preformulation parameters, packaging and process parameters, and the elimination of particulate matter.

The delivery agent-mediated transport of low moleular weight heparin across Caco-2 cells is accomplished without opening the junctions or adversely affecting the structural integrity of the cell monolayer.

Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.

The authors discuss the solubility and adhesive performances of adhesives that incorporate monomers such as hydroxyethyl acrylate or pyrrolidonoethyl acrylate.

To achieve the maximum performance from a tablet press run, operators must learn to distinguish between machine-related issues and granulation-related issues.

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