3PC-036 Case study: development of an ointment according to the Pharmaceutical Inspection Convention guideline

Abstract

Background and importance Haemorrhoid treatment has a significant community and hospital pharmacy burden. Treatment options are varied but in non-severe cases, topical is usually the form of administration selected. In this ointment, three pharmacological effects are combined, mainly found in commercial forms through a simple manufacturing procedure, accessible to the facilities of a hospital pharmacy laboratory.1 The Pharmaceutical Inspection Convention, published in March 2014, is a guideline for healthcare establishments to ensure the quality of medicines manufactured in pharmaceutical services. Aim and objectives To develop a semisolid pharmaceutical form for haemorrhoid treatment. This form contained a vasoconstrictor, local anaesthetic and glucocorticoid. Application of the current guidelines to the elaboration of medicines in the hospital pharmacy was applied.2 Material and methods Material: ointment base—vaseline, paraffin and levomenthol; APIs—phenylephrine hydrochloride, lidocaine hydrochloride and hydrocortisone. Equipment: electronic analytical scale pinacle; Agilent Series 1100 with quaternary pump and diode array detector; and ThermoScientific Haake Viscotester 550. The organoleptic characteristics and rheologic properties were assessed. Content homogeneity of the three APIs was proved through a high performance liquid chromatography (HPLC) validated method.3 Results A manufacturing system in the hospital pharmacy was developed following the concept of quality by design.4 A quality assurance system was established to supervise the whole manufacturing process and documentation. Full pharmaceutical characterisation was developed, including the development and validation of a HPLC method to quantify the three APIs in the ointment. Conclusion and relevance This work corroborates the fact that application of these guidelines in combination with the International Conference of Harmonisation instructions is both feasible and convenient in terms of manufacturing medicinal products in healthcare establishments. This methodology will be implemented in the manufacture of more complex medicinal products in subsequent work. References and/or acknowledgements 1. Brown SR. Haemorrhoids: an update on management. Ther Adv Chronic Dis 2017;8:141–147. 2. Pharmaceutical Inspection Convention. Guide to good practices for the preparation of medical products in healthcare establishments, 2014. 3. International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use. Validation of analytical procedures: Text and Methodology Q2 (R1). Geneva, 2005. 4. International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use. Endorsed guide for ICH Q8/Q9/Q10 Implementation. Geneva, 2011. No conflict of interest.