Excipients

CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.

BASF announces that it will sell its custom synthesis business and parts of its API business to focus its expertise on pharmaceutical excipients.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

Taste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

Ionic liquid technologies offer a new way to improve bioavailability.

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

DuPont Nutrition & Health has added a new pharmaceutical excipient to the portfolio of ingredients for CPhI Worldwide 2014, in Paris this October.

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients.

The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions.

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

The EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.

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

DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.

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

Lifecycle management opportunities are impacting the development of controlled-release technologies for solid-dosage drugs.

The author discusses various aspects of the hot-melt extrusion process and outlines a practical approach to scale-up.

Charlie Martin, Leistritz Extrusion, describes hot-melt extrusion manufacturing processes and advances.

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

A study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.

The selection of excipients is important in generic formulations due to the impact it has on the risk and performance of generic drugs.

Drug formulators are looking for new excipients to address solubility and bioavailability issues and extend patent protection, but there are hurdles to using novel, specialized ingredients.

Merck Millipore has introduced a new solubility/bioavailability enhancement excipient, Parteck SLC, which has a unique pore structure that enables higher loading of amorphous APIs, thereby, improving dissolution rates and increasing drug solubility.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.