Orally-disintegrating Tablets in Fixed-dose Combination Containing Ambroxol Hydrochloride and Salbutamol Sulphate...

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Formulation Development

Background:

• Respiratory disorders necessitate effective drug delivery systems for improved patient compliance.
• Ambroxol hydrochloride and salbutamol sulphate are key active pharmaceutical ingredients (APIs) for managing respiratory conditions.
• Orally disintegrating tablets (ODTs) offer an alternative dosage form for rapid drug absorption and administration ease.

Purpose of the Study:

• To formulate and develop orally disintegrating tablets (ODTs) containing a fixed-dose combination of ambroxol hydrochloride and salbutamol sulphate.
• To optimize the ODT formulation using superdisintegrants, binders, and excipients for enhanced dissolution and stability.
• To evaluate the in vitro characteristics and stability of the developed ODTs.

Main Methods:

• Orally disintegrating tablets (ODTs) were prepared using the direct compression method.
• Various concentrations of sodium starch glycolate (SSG) as a superdisintegrant and microcrystalline cellulose (MCC) as a binder were investigated.
• Tablets underwent comprehensive in vitro evaluations, including hardness, friability, wetting time, disintegration time (DT), drug content uniformity, and dissolution studies. Drug-excipient compatibility and accelerated stability studies were also performed.

Main Results:

• The optimized formulation contained 4% SSG and 1% MCC, achieving the lowest disintegration time (DT).
• The developed ODTs met all quality control specifications and FDA requirements for rapid-dissolving tablets, with over 85% drug release within 30 minutes.
• Fourier transform infrared spectroscopy (FTIR) confirmed no significant drug-excipient interactions, and accelerated stability studies indicated good formulation stability under various conditions.

Conclusions:

• A systematic formulation approach successfully developed stable and effective orally disintegrating tablets (ODTs) of ambroxol hydrochloride and salbutamol sulphate.
• The fixed-dose combination ODTs are economical and industrially feasible for treating respiratory disorders.
• The optimized formulation ensures rapid drug release, enhancing therapeutic potential.