The European Pharmacopoeia

Self-microemulsifying drug-delivery system (SMEDDS) can be defined as an isotropic system containing lipid and surfactant as well as cosurfactant that develop an emulsion in the aqueous fluid after slight agitation. Nearly half of the newly synthesized chemical molecules show less solubility in the aqueous phase, which is the major concern to the efficient delivery of drug molecules and hence decrease the bioavailability of these entities. In addition, SMEDDSs are considered as a prominent platform in resolving poor bioavailability of hydrophobic drugs through oral delivery. However, traditional self-emulsifying systems that are being developed using a liquid phase may exhibit few disadvantages such as in vivo precipitation of bioactive molecules, product handling problems, and restricted lymphatic transport. Moreover, these limitations restrict their prominent applications. In this context the addition of distinct polymeric precipitation inhibitors may facilitate the keeping of the drug in supersaturation state. Furthermore, solid-SMEDDS assist in combating both handling of liquid as well as stability-related issues. In addition the incorporation of medium-chain triglycerides along with antioxidants may also reduce oxidation-related issues of some unsaturated fatty acids. This chapter details in-depth report on distinct kinds of SMEDDS-based formulations via various route, dosage forms, composition, characterization, and their applications.

Self-microemulsifying drug-delivery system: ongoing challenges and future ahead

In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems.

/pdf/passive-transdermal-systems-whitepaper-incorporating-current-5cn00ar47c.pdf

Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles

In recent years, an increase in the discovery and development of biotherapeutics employing new modalities, such as bioconjugates or novel routes of delivery, has created bioanalytical challenges. The inherent complexity of conjugated molecular structures means that quantification of the bioconjugate and its multiple components is critical for preclinical/clinical studies to inform drug discovery and development. Moreover, bioconjugates involve additional multifactorial complexity because of the potential for in vivo catabolism and biotransformation, which may require thorough investigations in multiple biological matrices. Furthermore, excipients that enhance absorption are frequently evaluated and employed for the development of oral and inhaled biotherapeutics. Risk-benefit assessments are required for novel or existing excipients that utilize dosages above previously approved levels. Bioanalytical methods that can measure both excipients and potential drug metabolites in biological matrices are highly relevant to these emerging bioanalysis challenges. We discuss the bioanalytical strategies for analyzing bioconjugates such as antibody-drug conjugates and antibody-oligonucleotide conjugates and review recent advances in bioanalytical methods for the quantification and characterization of novel bioconjugates. We also discuss bioanalytical considerations for both biotherapeutics and excipients through novel administration routes and review analyses in various biological matrices, from the extensively studied serum or plasma to tissue biopsy in the context of preclinical and clinical studies from both technical and regulatory perspectives. 

/pdf/bioanalytical-methods-and-strategic-perspectives-addressing-1ngf3atg.pdf

Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics

Cashew gum is extracted from the exudate of the giant cashew tree (Anacardium occidentale L.). The objective of this work was to study the extraction and purification of cashew gum through experiments to characterize its structures and physicochemical and thermal properties, and to evaluate its use as a pharmaceutical excipient. The characterization of the materials was performed by infrared spectroscopy, thermogravimetric analysis and rheological studies of powder. Analysis of the material showed that it has reasonable flow characteristics and compressibility, allowing the use as diluent of tablets. Tablets were produced with a cashew gum isolated and purified by the direct compression method, and it was shown that the tablets produced with the purified cashew gum obtained better mechanical properties (hardness and friability) and less disintegration time than tablets made with gum of cashew isolated, suggesting the use of purified cashew gum as a diluent for this type of pharmaceutical form.

/pdf/evaluation-of-the-application-of-cashew-gum-as-an-excipient-6lfw1e20fq.pdf

Evaluation of the application of cashew gum as an excipient to produce tablets

IPEC has published Qualification of Excipients for Use in Pharmaceuticals detailing processes for developing and sourcing excipients and discusses issues that must be resolved for development of a commercial agreement. The document is divided into the Excipient Supplier's Process, the Users Process, and concludes with the Negotiation Process. The guideline provides a framework for suppliers and users of excipients to better understand the barriers to the introduction of new excipients and alternate sources of existing excipient grades. This dialogue provides for easier resolution of technical, safety, and regulatory issues concerning excipients. in December 2008, IPEC published Qualification of Excipients for Use in Pharmaceuticals. This guide of international applicability details processes for developing and sourcing excipients from the perspective of both the excipient supplier and user and provides a discussion of the issues that must be resolved to allow for development of a commercial agreement between the two parties. This article presents an overview/summary of the IPEC guide. IPEC is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising four regional pharmaceutical excipient industry associations covering North America, Europe, China and Japan (which are known respectively as IPEC-Americas, IPEC Europe, IPEC-China and JPEC). IPEC's objective is to contribute to the development and harmonisation of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of best practice and guidance concerning excipients.

Qualification of excipients for use in pharmaceuticals

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Qualification of excipients for use in pharmaceuticals