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Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
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Formulation, development, and in-vitro/ex-vivo evaluation of vaginal bioadhesive salbutamol sulfate tablets for

Amal S M Abu El-Enin1,2, Asmaa M Elbakry1,3, Rania El Hosary4

  • 1Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.

Pharmaceutical Development and Technology
|May 14, 2020
PubMed

Insights

New vaginal bioadhesive tablets containing salbutamol sulfate offer a promising, non-invasive treatment for preterm labor. This formulation aims to reduce side effects associated with conventional salbutamol sulfate methods.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Reproductive Health

Background:

  • Preterm labor is a major global health concern, causing significant infant and maternal mortality.
  • Current treatments for preterm labor, such as parenteral and oral salbutamol sulfate, can have adverse side effects.
  • Development of alternative, non-invasive drug delivery systems is crucial for improving patient outcomes.

Purpose of the Study:

  • To formulate non-invasive vaginal bioadhesive tablets of salbutamol sulfate.
  • To optimize tablet formulations using a full factorial design to enhance efficacy and minimize side effects.
  • To evaluate the potential of these novel tablets as a safer alternative for preterm labor management.

Main Methods:

  • A 4^1 × 3^1 × 2^1 full factorial design was employed to prepare 24 vaginal bioadhesive tablet formulations.
  • Key independent variables included polymer type (Carbopol 934, HPMC 4000, HEC, PEG 6000), polymer-to-drug ratio (1:1, 2:1, 3:1), and diluent (lactose, mannitol).
  • Formulations were assessed for drug content, mass variation, hardness, friability, swelling index, residence time, and in vitro drug release (T50%).

Main Results:

  • Polymer type and diluent significantly influenced both tablet residence time and the time for 50% drug release (T50%).
  • A strong positive correlation (0.91) was found between in vitro and ex vivo drug permeation studies.
  • These findings suggest good potential for in vivo performance of the developed salbutamol sulfate vaginal bioadhesive tablets.

Conclusions:

  • Salbutamol sulfate vaginal bioadhesive tablets represent a potentially successful and safer therapeutic option for managing preterm labor.
  • The non-invasive vaginal delivery system may overcome limitations and side effects associated with conventional salbutamol sulfate administration.
  • Further in vivo studies are warranted to confirm the clinical efficacy and safety of this novel formulation.

Keywords:
Salbutamol sulfatebioadhesive tabletsex-vivo permeationfull factorial designsustained release

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