Excipients

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

The low viscosity of Colorcon’s Opadry QX, even at solid levels as high as 35%, reduces coating and preparation time compared to traditional hydroxypropyl methylcellulose-based coatings.

Industry experts were honored for business, scientific, and social contributions.

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

Europe updates the guideline on excipients information in labeling and packaging.

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

Omya will be presenting its functionalized calcium carbonate for several applications at the show.

Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.

Polymers and surfactants impact stability and long-term performance.

Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.

Excipient manufacturer adds three tablet binding and disintegration products.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Ashland opened a new pharmaceutical excipient manufacturing facility in Nanjing, China.