Formulation

Almac is investing GBP16 million to expand its formulation and analytical development services and has successfully negotiated to operate in the Charnwood Campus in Loughborough, England.

The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation.

Capsugel has launched its enTRinsic drug-delivery technology platform. Using pharmaceutically approved enteric polymers, the technology offers full enteric protection without the need for functional coatings and enables targeted release of gastric acid- and heat-sensitive active ingredients in the upper gastrointestinal tract. The new technology platform expands Capsugel’s range of modified- and targeted-release solutions and biotherapeutic formulation offering, and can be used for oral delivery of drugs, including vaccines, proteins, and peptides.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

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.

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.

New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

Tuzistra XR for cough relief is said to be the only twice-daily, extended-release codeine-based cough and cold syrup available in the US.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel’s Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.

Experts from Dow Pharma & Food Solutions discuss the versatility of solid dispersions in solubility enhancement and the importance of pairing the active pharmaceutical ingredient to the optimal polymer.

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.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

Modern methods and modeling offer a better way to understand solubility issues and solve today’s complex formulation challenges.

Prodrugs and drug-delivery systems controlled by time, pH, and osmosis, are being used to prevent drug degradation in the stomach and large intestine and ensure drug release in the colon.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or biopolar I disorder.

Pharmaceutical companies are constantly aiming for shorter drug-development cycles and advances in formulation development produce significant benefits.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.

An integrated pilot plant tests heteronucleation and continuous crystallization.