Stability studies, recent trend and future prospects

6 October 2017

Pr J-D. Hecq1, Dr J. Vigneron2 1 University Hospital Dinant Godinne, Yvoir, Belgium
2 CHU Brabois, Vandoeuvre, France

Statements and perspective on drug stability studies

Pr J-D. Hecq

While the first intravenous injection was launched on the market in 1903, the first compatibility study was published in 1955. Followed by 2 others in 1961.

The first repertory of compatibility and stability studies appeared in the USA in 1971. Another competing repertory appeared in 1977. These two repertories are still operational and updated.

In 1977, one of the most widely cited compatibility studies was published, the 1: 1 mixture to study the stability of the IV medications flowing in a Y-site.

The publication of stability and compatibility studies will then spread. However, the modification of the Am J Health-Syst Pharm’s editorial policy will modify the number of publications since 1997 and reduce the number of posters at the annual congress of this association. Other Journals will publish this type of study and are currently close to thirty. Nearly 600 research teams have been registered worldwide, including 233 in Europe.

A survey of the international and national European databases active to date has been carried out. Only 3 European countries possess such a database, the result of personal work or supported by a working group of the local Association of Hospital Pharmacy.. All these thesauri are available in paper or electronic format. However, reading these different sources can make discover contradictory data. It is therefore necessary at this time to obtain these publications and to read them carefully. Seven criteria for assessing the quality of a physico-chemical stability publication have been identified and published recently.

The citation of R. Hasegawa in 1994 remains valid: "Caring about stability and compatibility may not excite many pharmacists. However, no other health professionals are as qualified or as obligated to effectively apply their training and experience and the abundance of published data to this aspect of patient care”.

Stabilis® : New function « Research teams» - A bridge between users and researchers

Dr J. Vigneron

The new function was opened in April 2017 and concerns the research teams in the world which have articles selected in Stabilis®. This is the first published database of research teams in stability.

We have created five new screens: the list of research teams, the search function, the team’s characteristics, a global map to visualize the location of the teams in the world and the list of stability studies proposed by the users.

1 - The list of research teams is sorted by country and by town with the type of team (hospital, laboratory or university), the name of the structure, the number of references published and the year of the last publication.
594 teams are registered in Stabilis® and 140 are still active (publications during the past 5 years).

2 - A multicriteria search screen allows to select a compound’s name, a galenic form (injectable, oral solution, eye-drops, etc), a pharmacological class, a form of the molecule (small molecule, liposome, monoclonal antibody, other proteins and Non Biological Complex drugs (NBCD)), a country, a continent, an author’s name and a year with all the functions (=, <=, <, >=, >).

3 - A team datasheet for each team is available with the country flag, team type, address, Google map and the team photo (it can be also a photo of the hospital or the university). Next, all published bibliographic references and molecules studied are listed. The email address of the team allows the contact of the responsible of the team by the users. This pdf file can be downloaded.

4 - The world map edited by Google to see the location of the teams.

5 - The list of stability studies proposed by the Stabilis users to the website (opened in September 2017)
The topics are analyzed by the Stabilis team, the proposal is activated if the subject is considered interesting and key-words are defined by Stabilis

This new function is considered as a bridge between users and researchers. We hope this function will stimulate the research in stability, which is a mission defined in the Good manufacturing Practices. This scientific mission is supported by excellent guidelines established by French pharmaceutical Societies: SFPO (French Society of Oncology Pharmacy): Guidelines for the practical stability studies of anticancer drugs) and SFPC (French Society of Clinical Pharmacy) in collaboration with GERPAC (Evaluation and Research Group on Protection in Controlled Atmospher): Methodological guidelines for stability studies of hospital pharmaceutical preparations.

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