Assessment of the relevance of osmolality measurement as a criterion for the stability of solutions

Author:

Vigneron Jean12,Sacrez Matthieu1,D’Huart Élise12,Demoré Béatrice123

Affiliation:

1. Service de Pharmacie , Centre Hospitalier Universitaire Régional de Nancy , Vandœuvre-lès-Nancy , France

2. Infostab, Non-profit Association , Heillecourt , France

3. Université de Lorraine , Nancy , France

Abstract

Abstract Objectives The measurement of osmolality is used by many authors as an additional stability criterion of a drug in solution. In the current state of knowledge, no scientific publication correlates the osmolality values and the stability of a solution. To study the relevance of this analytical technique by measuring the osmolality of injectable solutions whose instability has been chemically demonstrated by high performance liquid chromatography (HPLC). Methods Selection of 13 drug preparations whose chemical instability has been demonstrated in the literature. Realization of three identical samples per selected preparation and measurements of the osmolality of the freshly prepared solutions, then, at various storage times until a chemical degradation of the molecule validated by HPLC of at least 10% and possibly up to 40%. Results Measurements of the osmolality were performed on five antibiotics (amoxicillin/clavulanic acid, cefepime, cefoxitine, meropenem and temocillin and cefoxitin) and five anticancer drugs (azacitidine, bendamustine, busulfan, fotemustine and oxaliplatin). Osmolality varied from −6.30 to 11.10% for antibiotics and from 0.57 to 2.04%. Conclusions Among the preparations tested, only two formulations have a variation in osmolality in accordance with the chemical degradation. For the other 11 formulas, the variations in osmolality values where not correlated with the degradation measured by HPLC. In view of these results, osmolality does not seem to be a criterion of choice for the study of drug stability. In the majority of the unstable solutions studied, the variation of osmolality measurements does not correlate with the loss of concentration and the appearance of degradation products.

Publisher

Walter de Gruyter GmbH

Subject

Pharmacology (medical),Pharmacology,Pharmacy

Reference21 articles.

1. European Pharmacopoeia 10.0. 2.2.35. Osmolality, 10th ed. Strasbourg, France: Council of Europe; 2019:20235 p.

2. Des Robert, C. Nutrition parentérale en néonatologie. Haute autorité de santé; 2018. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2018-06/argu_np_neonat_2018-06-28_11-18-23_280.pdf.

3. Akers, MJ. Basics of sterile compounding: excipients used in injections. Int J Pharm Compd 2017;214:301–8.

4. Allen, LV. Quality-control analytical methods: osmolality and osmometry. Int J Pharm Compd 2004;8:143–5.

5. Santillo, M. A Standard protocol for derivation and assessment of stability – Part 4: Parenteral nutrition. National Health Service; 2016. Available from: https://www.sps.nhs.uk/wp-content/uploads/2017/06/NHS-PQAC-YCD-Std-Protocol-Chemical-Stability-Part-.

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