Salbutamol 10

Orals

Salbutamol 10

Salbutamol 10 is a pharmaceutical tablet formulation of Salbutamol Sulphate at 10 milligrams per tablet. Salbutamol (albuterol in North American nomenclature) is a short-acting, selective beta-2 adrenergic receptor agonist that was first introduced in 1969 and remains one of the most widely prescribed bronchodilators in clinical medicine. At higher oral doses, its selective stimulation of beta-2 receptors in adipose tissue and skeletal muscle produces thermogenic and mild anabolic effects of pharmacological significance.

Structural Profile and Receptor Selectivity

Salbutamol is a phenylethylamine derivative with a saligenin scaffold, structurally related to adrenaline but with substitutions that dramatically increase beta-2 receptor selectivity relative to beta-1 and alpha adrenoceptors. This receptor selectivity profile produces bronchodilation and thermogenesis at doses that produce minimal cardiovascular (beta-1) stimulation compared to non-selective beta agonists. The sulphate salt formulation provides improved stability and dissolution characteristics relative to the free base.

Pharmacokinetic Profile

Oral salbutamol sulphate is incompletely absorbed from the gastrointestinal tract with bioavailability of approximately 30–50% owing to extensive presystemic sulphate conjugation in the intestinal wall. Peak plasma concentrations are reached within 2–3 hours of oral administration. The plasma elimination half-life is 4–6 hours. Salbutamol is primarily eliminated by hepatic metabolism to an inactive 4-O-sulphate conjugate, with the remainder excreted unchanged in urine. Detection in urine is achievable for approximately 24 hours by immunoassay.

Mechanism of Action

Salbutamol stimulates beta-2 adrenoceptors coupled to Gs proteins, activating adenylate cyclase and elevating intracellular cAMP. In smooth muscle, elevated cAMP drives protein kinase A phosphorylation of myosin light chain kinase, producing muscle relaxation and bronchodilation. In adipose tissue and skeletal muscle, cAMP elevation activates hormone-sensitive lipase driving lipolysis, increases metabolic rate, and produces anti-catabolic effects in skeletal muscle via reduced ubiquitin-proteasome pathway activation. Unlike clenbuterol, salbutamol's significantly shorter half-life limits the degree of beta-2 receptor down-regulation with routine use.

Formulation

Each Salbutamol 10 tablet contains 10 mg Salbutamol Sulphate IP as active ingredient, manufactured to Indian Pharmacopoeia specification under GMP-compliant conditions. Pharmaceutical excipients include microcrystalline cellulose, lactose monohydrate, povidone, and magnesium stearate. Complete release testing including HPLC concentration verification, purity analysis, dissolution testing, and microbiological limits evaluation is performed on every batch prior to release.

Quality Assurance

Every batch of Salbutamol 10 produced by Biomedica undergoes the complete pharmaceutical release testing protocol before distribution. This includes HPLC compound identity confirmation and purity analysis (specification: ≥98%), concentration verification (specification: ±5% of label claim), sterility testing per USP <71>, bacterial endotoxin quantification by LAL assay (specification: <0.25 EU/mL), and particulate matter inspection per USP <788>. A Certificate of Analysis is issued for every production lot.

Authentication

Each unit of Salbutamol 10 carries a unique authentication code on its outer packaging. This code can be verified instantly on our Authentication page to confirm the product is genuine Biomedica stock.