Pharmaceutical Analysis and Drug Stability Evaluations

Dear Colleagues,

It is well-known that pharmaceutical analysis plays an essential role in the development of new dosage forms, not only for the original formulations newly developed by pharmaceutical giants, but also for the release of generics.

The development of new pharmaceutical formulations is correlated not only with the pharmacological effect of the bioactive molecule, but also with the physico-chemical profile of the compound, which must be rigorously analyzed. Since this profile determines the stability and reactivity of the drug, its interactions with excipients and solubility are of the utmost importance, necessitating the performance of in-depth analyses that reveal these parameters. Furthermore, a comprehensive physico-chemical profile gives clear indications regarding the technological processes that must be chosen during the preformulation and formulation stages. The adequate selection of these steps has a direct influence on the bioavailability of the active pharmaceutical ingredient when administered as the designed dosage form.

Preformulation studies are essential in revealing the possible impediments that may occur before or during the production of the final pharmaceutical formulation. These offer adequate solutions to avoid these issues, no matter the type of the pharmaceutical form (liquid, semi-solid, or solid, with systemic or local action). In the preformulation phase, a series of properties are analyzed regarding the active substance, the possible and selected excipients, and the active substance–excipient mixtures, such as stability in solution or in solid state (both in ambient conditions and under thermal stress), dissolution profile, the formation of binary adducts (salts, cocrystals, or supramolecular assemblies), and these tests are performed using advanced instrumental techniques.

This Special Issue is focused on original research papers that cover pharmaceutical analysis and drug stability evaluation in the preformulation and/or formulation stage for active pharmaceutical ingredients that are no longer protected by patents. The performed studies should be based on advanced instrumental techniques and the results revealed in order to offer viable solutions for the development of new generic dosage forms, with increased stability and longer shelf-life, facilitating the access of patients to cheaper therapeutic alternatives with the same biological effects as the original formulations. Scientists that are focused on this domain are encouraged to submit their research results for publication in this Special Issue. Additionally, review papers that present an in-depth analysis of the state of the art in the preformulation/formulation of a certain active pharmaceutical ingredient are also eligible.

Prof. Dr. Adriana Violeta Ledeți
Dr. Laura Sbârcea
Dr. Denisa Laura Cîrcioban
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Molecules is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• drug stability and stabilization techniques
• instrumental analysis of active pharmaceutical ingredients
• heterogenous degradation of drugs
• solid-state kinetics
• supramolecular systems with increased biopharmaceutical profile

• Pharmaceutical Analysis and Drug Stability Evaluation in Molecules (4 articles)