Formulation

Conventional tablets may no longer be the go-to solution.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

Experts from Capsugel and Catalent discuss the rationale of using lipid0basd formulations to improve the oral bioavailability of poorly soluble drugs.

New chemical entities with poor aqueous solubility require the use of technologies to enable sufficient oral bioavailability of these NCEs following administration.

Stephen Tindal from Catalent Pharma Solutions speaks with Pharmaceutical Technology Europe about advances in softgel technologies.

Softgels are now being recognised as one of the preferred dosage forms for the treatment of pain, eye conditions, cough and cold, as well as allergy.

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Study provides first substantive reference data on key quality attributes of empty capsules

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

Experts share insights on how product appearance such as size, shape, color, and imprint can make a difference in reducing medication errors.

The author examines the effect of compaction force, gap width, and sieve setup on granule size.

Encapsulation technologies for solubility/bioavailability enhancement, controlled release, and formulation of drug combinations and patient-friendly dosage forms.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.

Accelerated testing and production create challenges in documenting product quality.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.