Article Text

other Versions

PDF
Development and stability study of glibenclamide oral liquid paediatric formulations for the treatment of permanent neonatal diabetes mellitus
  1. Pablo Estevez1,
  2. Oriana Boscolo1,
  3. Eduardo Quiroga1,2,
  4. Rocio Fernandez Penuto3,
  5. Fabian Buontempo1,3,
  6. Valeria Tripodi1,4,
  7. Silvia Lucangioli1,4
  1. 1Department of Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry, University of Buenos Aires, Buenos Aires, Argentina
  2. 2Quality Control Laboratory, College of Pharmacists of Buenos Aires Province, La Plata, Argentina
  3. 3Pharmacy Service, Pediatric Hospital J P Garrahan, Buenos Aires, Argentina
  4. 4National Scientific and Technical Research Council (CONICET), Argentina
  1. Correspondence to Silvia Lucangioli, Department of Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry, University of Buenos Aires, Junin 956, Buenos Aires, Buenos Aires 1113, Argentina; slucangi{at}ffyb.uba.ar

Abstract

Background Glibenclamide is a second-generation oral sulfonylurea used to treat neonatal permanent diabetes mellitus. It is more effective and safer than the first-generation agents. However, no liquid oral formulation is commercially available and, therefore, it cannot be used for individuals who cannot swallow the solid form.

Objectives To develop and study the physicochemical and microbiological stability of two liquid glibenclamide formulations for the treatment of permanent neonatal diabetes mellitus: two suspensions (2.5 mg/mL)—one using glibenclamide raw material and the other, glibenclamide tablets. Furthermore, high-performance liquid chromatography (HPLC) stability showed that the method is optimised and validated for analysis of glibenclamide in the formulations studied.

Methods Samples were stored at 4°C, 25°C and 40°C. The amount of glibenclamide in each formulation was analysed in duplicate using HPLC at 0, 7, 14, 28, 60 and 90 days. Other parameters were also determined—for example, the appearance, pH and morphology. Microbiological studies according to the guidelines of the US Pharmacopoeia for non-sterile products at 0 and 90 days were carried out.

Results All formulations remained physicochemically and microbiologically stable at three different temperatures during the 90-day study. Therefore, glibenclamide formulations can be stored for at least 90 days at ≤40°C.

Conclusions These formulations are ideally suited for paediatric patients who usually cannot swallow tablets. The proposed analytical method was suitable for studying the stability of different formulations.

  • PAEDIATRICS

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.