Development of Losartan Orally Disintegrating Tablets by Direct Compression: a Cost-Effective Approach to Improve Paediatric Patient’s Compliance

The development of suitable dosage forms is essential for an effective pharmacological treatment in children. Orally disintegrating tablets (ODTs) are attractive dosage forms that avoid swallowing problems, ensure dosage accuracy and are easy to administer as they disintegrate in the oral cavity. Th...

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Published in:AAPS PharmSciTech 2024-04, Vol.25 (4), p.79-79, Article 79
Main Authors: Juan, Candela, Gallo, Loreana, Gonzalez Vidal, Noelia
Format: Article
Language:English
Subjects:
Administration, Oral
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Child
Cost-Benefit Analysis
Drug Compounding - methods
Excipients
Hardness
Humans
Hypertension - drug therapy
Losartan
Pharmacology/Toxicology
Pharmacy
Research Article
Solubility
Tablets
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creator Juan, Candela
Gallo, Loreana
Gonzalez Vidal, Noelia
description The development of suitable dosage forms is essential for an effective pharmacological treatment in children. Orally disintegrating tablets (ODTs) are attractive dosage forms that avoid swallowing problems, ensure dosage accuracy and are easy to administer as they disintegrate in the oral cavity. This study aimed to develop ODTs containing losartan potassium (LP) for the treatment of arterial hypertension in children. The ODTs, produced by the cost-effective manufacturing process of direct compression, consisted of a mixture of diluent, superdisintegrant, glidant and lubricant. Five superdisintegrants (croscarmellose sodium, two grades of crospovidone, sodium starch glycolate and pregelatinized starch) were t ested (at two concentrations), and combined with three diluents (mannitol, lactose and sorbitol). Thus, thirty formulations were evaluated based on disintegration time, hardness and friability. Two formulations, exhibiting the best results concerning disintegration time (
doi_str_mv 10.1208/s12249-024-02796-9
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These ODTs presented favourable drug-excipient compatibility, tabletability and flow properties. The in vitro dissolution studies demonstrated ‘very rapid’ drug release. Preliminary stability studies highlighted the requirement of a protective packaging. All quality properties retained appropriate results after 12 months of storage in airtight containers. In conclusion, the ODTs were successfully developed and characterised, suggesting a potential means to accomplish a final prototype that enables an improvement in childhood arterial hypertension treatment. 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These ODTs presented favourable drug-excipient compatibility, tabletability and flow properties. The in vitro dissolution studies demonstrated ‘very rapid’ drug release. Preliminary stability studies highlighted the requirement of a protective packaging. All quality properties retained appropriate results after 12 months of storage in airtight containers. In conclusion, the ODTs were successfully developed and characterised, suggesting a potential means to accomplish a final prototype that enables an improvement in childhood arterial hypertension treatment. 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source Springer Nature
subjects Administration, Oral
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Child
Cost-Benefit Analysis
Drug Compounding - methods
Excipients
Hardness
Humans
Hypertension - drug therapy
Losartan
Pharmacology/Toxicology
Pharmacy
Research Article
Solubility
Tablets
title Development of Losartan Orally Disintegrating Tablets by Direct Compression: a Cost-Effective Approach to Improve Paediatric Patient’s Compliance
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