Formulation, development, and in-vitro/ex-vivo evaluation of vaginal bioadhesive salbutamol sulfate tablets for preterm labor.

Abstract:

:Preterm labor is the main cause of death and serious illness of both infants and pregnant women in Africa and worldwide. Parenteral and oral salbutamol sulfate as a B2 antagonist has been used for the treatment of preterm labor. The study aims are to formulate salbutamol sulfate non-invasive vaginal bioadhesive tablets to avoid the side effects of conventional formulations. Full factorial design 41 ×31 ×21 was used for the preparation of 24 vaginal bioadhesive tablet formulations. The independent factors were polymer type (Carbopol 934, HPMC 4000, HEC, and PEG 6000), polymer to drug ratio (1:1, 2:1, and 3:1), and diluent (lactose and mannitol). Vaginal bioadhesive tablets were evaluated for residence time and time required for release 50% of salbutamol sulfate T50% as dependent variables. The formulations were evaluated in terms of drug content, mass variation, hardness, friability, swelling index, residence time, and in-vitro drug release. Results revealed that polymer and diluent types are the most significant factors in both residence time and T50%. A strong positive correlation (0.91) between in-vitro and ex-vivo permeation was observed, which predict the best in-vivo performance of salbutamol vaginal bioadhesive tablet. Thus, salbutamol sulfate vaginal bioadhesive tablets could be a successful remedy for preterm labor.

journal_name

Pharm Dev Technol

authors

El-Enin ASMA,Elbakry AM,Hosary RE,Lotfy MAF

doi

10.1080/10837450.2020.1767129

subject

Has Abstract

pub_date

2020-10-01 00:00:00

pages

989-998

issue

8

eissn

1083-7450

issn

1097-9867

journal_volume

25

pub_type

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