Safe use of Dexamethasone in pediatrics: design and evaluation of a novel stable oral suspension

Abstract

<jats:title>Abstract</jats:title> <jats:sec id="j_pthp-2018-0003_s_007"> <jats:title id="d23481e325">Background</jats:title> <jats:p>Dexamethasone is used in pediatrics mainly for treatment of croup and bronchopulmonary dysplasia. Commercially available pediatric oral formulations include inadequate excipients for this population. When there are only commercially available oral dosage forms for adults, a formulation is prepared to reduce the dose by manipulation of authorized tablets or injectable dosage forms. This practice most of times is made without the quality and control that process requires. The aim of this study is to propose a formulation secure and suitable for pediatrics by the use of a Standard Operating Procedure that ensures its quality.</jats:p> </jats:sec> <jats:sec id="j_pthp-2018-0003_s_008"> <jats:title id="d23481e334">Methods</jats:title> <jats:p>Design of two formulations was performed with lowest number and amount of excipients suitable for pediatrics, avoiding use of dexamethasone salts and preservatives. An accurate and precise analytical method and a methodology for analyzing uniformity of doses were developed. Physical, chemical and microbiological stability was tested.</jats:p> </jats:sec> <jats:sec id="j_pthp-2018-0003_s_009"> <jats:title id="d23481e343">Results</jats:title> <jats:p>Stability of Dexamethasone was improved by acidification with citric/citrate buffer. Proposed suspension complies with quality criteria required for an oral non-sterile formulation using Dexamethasone as active pharmaceutical ingredient, and the minimum number and quantity of excipients suitable for pediatrics.</jats:p> </jats:sec> <jats:sec id="j_pthp-2018-0003_s_010"> <jats:title id="d23481e352">Conclusions</jats:title> <jats:p>This formulation is physical, chemical and microbiologically stable during 15 days storage at 5 and 25°C.</jats:p> </jats:sec>

Solid Dosage Forms of Dexamethasone Sodium Phosphate Intended for Pediatric Use: Formulation and Stability Studies

“…Dexamethasone sodium phosphate (DSP) is a glucocorticosteroid utilized for the treatment of many inflammatory conditions, such as allergic disorders, ulcerative colitis, arthritis, psoriasis, etc. According to the World Health Organization (WHO), DSP is considered to be one of the most effective and safest medicines [4,5] for a lot of therapeutic schemes. In the human body, DSP is hydrolyzed rapidly by phosphatases producing its free form [6].…”