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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 11
First page : ( 4939) Last page : ( 4945)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00899.5

Formulation and Evaluation of Pediatric Oral Soft Jellies of Salbutamol Sulphate

Begum Sk Arifa1,*, Sree V Padma2, Anusha V2, Veronica Z Keerthi2, Sree P Vinitha2, Prameela K2, Nazeema MD2, Padmalatha K2

1Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur-522034, Andhra Pradesh, India

2Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada-521108, Andhra Pradesh, India

*Corresponding Author E-mail: arifashaik2007@gmail.com

Online published on 30 January, 2019.

Abstract

Medicated oral jelly formulations are more preferable for pediatric patients, which provide rapid dissolution and absorption of drugs thereby early onset of action. The aim of the present investigation was to formulate and evaluate oral jelly formulations of salbutamol sulphate. Salbutamol sulphate oral jellies were prepared using gelatin alone, methyl cellulose‑gelatin and sodium carboxy methyl cellulose-gelatin in combination as gelling agents. The prepared jelly formulations were evaluated for pre-formulation studies, physical characteristics, drug content, pH, rheological properties, syneresis and in vitro dissolution testing. Fourier transform infrared analysis showed that there was no incompatibility between drug and excipients. The pH of all the formulations was found between pH 6.54 ± 0.06 and 6.74 ± 0.02. The weight variation was found between 0.99% ± 1.24 and 1.01% ± 0.74 in all prepared jelly formulations. The drug content was found in the range of 98.23% ± 0.58 to 99.25% ± 0.35, which was in conformity with the pharmacopoeial specification of 98%-101%. Syneresis was not observed in jellies. All formulations showed more than 50% drug release within 15 min. From the results of in vitro dissolution study, it was found that the rate of dissolution of salbutamol sulphate from F5 (gelatin-methyl cellulose combination) and F7 (gelatin-sodium CMC combination) was found to be higher and in conformance with the bio-pharmaceutical classification system (BCS) concept for the immediate release formulations (>85% in 30 min).

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Keywords

Salbutamol sulphate, paediatric patients, oral jelly, gelling agents.

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