Solid/Semi-Solid Dosage

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

With the acquisition of Medipac’s tube filling assets for effervescent tablets, Romaco can now offer the complete line configurations for effervescent tablets.

Integrated pharmaceutical blister-packaging equipment systems strengthen serialization and brand protection capabilities.

Dynamic powder testing and measurement of bulk powder properties can complement shear cell testing to identify the causes of poor hopper performance in solid-dosage drug manufacturing.

Experts at the ISPE annual meeting describe best practices, including containment and production in classified spaces.

AstraZeneca’s solid-dose facility in Taizhou, China received ISPE’s FOYA 2015 Overall Winner award.

A rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

Catalent Pharma Solutions won the “Innovation in Process and Formulation Development” category at the annual CPhI Pharma Awards, for its OptiShell softgel technology platform.

The Quad Pulse Package PX dust collector from Camfil Air Pollution Control is a compact unit for processes that produce hazardous dusts in high concentrations, with a cleanable filter system that facilitates continuous manufacturing.

Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

The Krämer KCP10 upward-conveying capsule polisher elevates, polishes, and dedusts capsules.

Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.

Elizabeth Scheu & Kniss will supply replacement parts for Bosch capsule filling machines.

WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.