Dosage Forms

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

The author provides an overview of QbD implmentation for biopharmaceuticals.

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

HHS Releases a New National Vaccine Plan

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Alfa Laval and GE Healthcare.

The application of the first piston syringes to treat medical complications was described in Roman times during the 1st century, and forms of intravenous injection and infusion began as early as 1670.

Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

Dishman is giving a step further in its strategy to manufacture high potency (HiPo) Active Pharmaceutical Ingredients (APIs).

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

World AIDS Day 2010 reminds us that prevention and hope can help fight the disease.

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

The growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.

A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.

FDA Holds Biosimilars Public Hearing

Industrial and academic partnerships forge new territory in solid-state chemistry.

Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.

The authors demonstrated that ODTs can be obtained by direct compression of a mixture of starch, fructose, and SMCC.

The author reviews key considerations for formulating powders for use in inhalers. This article is part of a special Drug Delivery issue.

A review on the current status of long-acting injectables, including commercially marketed products. This article is part of a special Drug Delivery issue.

The authors describe an alternative approach to compressing and coating minitablets for use in a sustained-release, solid oral-dosage form. This article is part of a special Drug Delivery issue.

The author outlines how to choose carriers and capsule shells according to dosage requirements and intended use. This article is part of a special Drug Delivery issue.

The author reviews advances in technology that may soon allow transdermal delivery of two of the fastest growing drug classes on the pharmaceutical market. This article is part of a special Drug Delivery issue.

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.

Pfizer announced this his week that it had entered into a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon (Bangalore) for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro).

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.