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…
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