Formulation

Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

In-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

The right partner can help companies overcome key formulation challenges for biologic drugs.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

A development agreement will study inhaled formulations of cannabinoid-based drug product for central nervous system diseases.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

This paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

More complex and challenging compounds require a more tailored approach to formulation strategies.

Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.

Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.

Tight development timelines and accelerated approval pathways favor simple, cost-effective capsule formulations.

End-user considerations are becoming increasingly important as they can provide a lot of value and help to ensure commercial success of a drug.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.