A statistical support for using spectroscopic methods to validate the content uniformity of solid dosage forms

Abstract The aim of the work described in this paper was to provide a fast, easy, inexpensive, precise, and accurate method for the determination of melatonine in solid pharmaceutical dosage forms. The developed method is based on a UV first-derivative spectrophotometric determination, which exhibits excellent linearity in aqueous solutions (r2 = 0.996) for analyte concentrations of 1.5–4.5 mg/dL within a pH range of 5–9. Neither excipients present in the formulation nor indole adulterants, such as tryptophan (up to 5%), interfere with the assay. A study of variation parameters showed that sonication temperature was the main factor for successful determination. At temperatures of <45°C, the sample dissolved completely, and accurate spectrophotometric measurements were obtained. A study was conducted of all the parameters established by the United States Pharmacopeia, 23rd Rev., to validate an analytical method for a solid pharmaceutical form, i.e., linearity, range, accuracy, precision, and specificity. All the parameters were in accordance with the acceptance criteria of the Comité de Guías Oficiales de Validación de la Dirección General de Control de Insumos para la Salud de Méjico. In addition, robustness and content uniformity tests were performed to substantiate the usefulness of the method.

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Multiparticulate oral formulations as a viable strategy for precise drug dosing in pediatrics: Propranolol case study

Arhiv za farmaciju ◽

10.5937/arhfarm71-30717 ◽

2021 ◽

Vol 71 (2) ◽

pp. 141-159

Author(s):

Ivana Kurćubić ◽

Sandra Cvijić ◽

Milica Lukić ◽

Svetlana Ibrić ◽

Jelena Đuriš

Keyword(s):

Drug Dose ◽

Dosage Forms ◽

Content Uniformity ◽

Propranolol Hydrochloride ◽

Solid Dosage Forms ◽

Drug Dosing ◽

Average Mass ◽

Solid Dosage ◽

Oral Formulations

The development of solid dosage forms that are both convenient for administration and allow precise drug dosing for pediatric patients is one of the great challenges in contemporary pharmaceutical technology. The presented study has utilized propranolol hydrochloride, as one of the most frequently prescribed drugs that require manipulation of the conventional dosage forms to be administered to children. Multiparticulate oral formulations, powderand granulefilled capsules, as well as mini tablets, were prepared and characterized in terms of their mass and content uniformity and compared to conventional marketed tablets split into halves and quarters. The obtained results have demonstrated the superiority of the multiparticulate formulations, in terms of their average mass and drug content uniformity. It has also been demonstrated that, due to improved flowability, granule-filled capsules are more conveniently compounded and provide higher content uniformity compared to powder-filled capsules. The presented compounding method could be easily employed in community pharmacy settings. Mini tablets with high and uniform content of propranolol hydrochloride have been successfully prepared, thereby presenting a viable strategy for efficient drug dose adjustment.

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