Manufacturing, Drug Products

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

Although patient compliance problems have been receiving attention for at least a decade, many medications are still dispensed in bottles that contain a supply intended to last days or weeks and require considerable effort on the part of the patient or caregiver to keep track of the dosing schedule. As a result, when it comes to consistently taking the right dose at the right time for the duration of a prescription, many consumers don't do a very good job.

This review article discusses orally disintegrating tablets and their manufacturing technologies, development issues, and future trends.

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

Cephalon partners with hardware and software providers to test item-level tagging.

Pharmaceutical science and technology innovation

Solid dosage form manufacturers have long relied on shape and color as well as on-pill imprints of logos, product names, or numbers for product identification. But in these days of heightened counterfeiting concerns, the industry has a growing interest in adding more difficult-to-duplicate features to the pool of existing product identification techniques. Added security is particularly important on high-profile or high-cost drugs, as well as on pharmaceutical products supplied in bulk for repackaging.

Self-Assembly Nanotechnology Improves Microencapsulation

Once considered mainly an afterthought in a company's lifecycle-management strategy, controlled-release dosage forms are now positioned at the forefront of many formulation strategies. In contrast to drug discovery, formulation work focuses not only on the intricacies of the active pharmaceutical ingredient (API), but also on fine-tuning the excipients, the release profile, and the delivery mechanism to provide optimal therapeutic benefit. Because of their wide range of applications and functionalities, especially in controlled-release therapies, polymers are among the most widely used excipients.

Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques.

The unit-dose bar coding rule requires integrating many aspects of packaging design and control.

A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.

Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.

RFID and battery-powered containers are among the developments receiving attention in the pharmaceutical cold chain.

The principles of direct compression haven’t changed in more than a century. So why can the topic still pack a ballroom?

The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.

To meet the requirements of the USP ?755? Minimum Fill and ?698? Deliverable Volume tests, target fill levels greater than 100% must be established. This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.

Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug

Albumin-Bound Nanoparticle Drug Nabs FDA Approval

From solving complex formulation challenges to delivering full product-development programs, outsourcing services organizations provide valuable expertise, experience, and technical know-how.

A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.

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

Freeze pelletization is a new and simple technique for producing spherical pellets for pharmaceutical use.

Stakeholders consider ways to improve printed patient inserts.

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

Particulate generation and durability concerns are encouraging pharmaceutical manufacturers to seek alternatives to wood pallets.

This month's column highlights some of the latest innovations in packaging seen at this year's Interphex conference.

Comprehensive Web sites, journals, and other sources help pharmaceutical makers find packaging-related data quickly and easily.