04. May 2018
This study explores the methodology advised by healthcare professionals and the methods used by parents/carers to identify whether there is a best practice method for manipulation of 10 mg hydrocortisone tablets to provide an accurate dose to children. Bespoke surveys were used to identify methods recommended and used in manipulation of tablets. Hydrocortisone tablets were manipulated to provide a specified dose by both naïve participants and parents/carers. The accuracy of manipulation was...
05. February 2018
Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of
2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed
to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative f
14. September 2017
Prof Martin Whitaker (The University of Sheffield) will present Infacort®: a PUMA success story at the 9th conference of the European Paediatric Formulation Initiative (EuPFI) in Warsaw (Poland) on Thursday 21st September 2017 at 12:25.
25. January 2017
Abstract Background: We developed a modified-release hydrocortisone, Chronocort®, to replace the cortisol rhythm in patients with congenital adrenal hyperplasia. Food, alcohol and pH affect drug absorption and it is important to assess their impact when replicating a physiological rhythm. Subjects and Methods: In vitro dissolution to study impact of alcohol and pH on Chronocort®. A Phase 1, three-period, cross over study in 18 volunteers to assess the impact of food on Chronocort® and to...
06. June 2016
Application of thermogravimetry (TG) alone to study compatibility/incompatibility of active pharmaceutical ingredients (APIs) with excipients yields to misleading results due to overlapping of the thermal stages in the course of decomposition of both ingredients and their pharmaceutical mixtures. Hence, the purpose of this study was to assess the usefulness of multivariate statistical analysis as a supporting tool for interpretation of the TG traces during assessing compatibility of...
10. June 2015
The application of bad tasting, often bitter APIs to children requires in most cases an effective taste optimisation. This can be achieved either by the addition of flavors or by masking the bad sensation. More
05. March 2015
Current treatment for adrenal insufficiency in neonates and infants is unsatisfactory as unlicensed adult formulations are used and the minimum unit dose available is a scored 5mg hydrocortisone tablet. These are difficult to administer to neonates and give rise to inconsistencies in dose as content uniformity of crushed tablets cannot be verified. We have developed a new formulation, Infacort®, specifically designed for infants and neonates… more...