This document describes the formulation and evaluation of immediate release salbutamol tablets using different proportions of crospovidone as a disintegrating agent. Three formulations were developed with crospovidone levels of 40 mg, 30 mg, and 20 mg. The tablets were evaluated for physical properties, disintegration time, dissolution, and drug content. Formulation 1 with 40 mg crospovidone showed the fastest disintegration time of 2.5 minutes and highest drug release. Further studies are recommended to assess bioavailability in human volunteers and long-term stability testing.

1. Prepared by:
Md. Suzon Ali
Roll: 383
Batch: 13th
Reg No: WUB 14/15/13/383
Department of Pharmacy

2. Any drug delivery is the most widely utilized route of
administration among all the routes that have been explored for the
systemic delivery of drug via pharmaceutical products of different
dosage form. Oral route is considered most natural, uncomplicated,
convenient and safe due to its ease of administration, patient
acceptance, and cost effective manufacturing process. Salbutamol
sulphate is a sympathomimetic agent acting on the β2-adrenergic
receptor shows site-specific absorption in the stomach and is used as
a bronchodilator in the treatment of reversible bronchospasm. The
drug has plasma half-life range from 2-4hr and the maximum
plasma drug concentration occurs within 2.5hr.

3. Salbutamol
CAS Registry Number: [18559-94-9]
Molecular Weight: 239.31g/mol
Molecular Formula: C13H21NO3
Melting Point: 157-158oC (with
decomposition)
Chemical Name: 1-(4-hydroxy-3-
hydroxymethylphenyl)-2-(t-
butylamino)-ethanolsulphate.
Description: A white oral most white,
crystalline powder. Clear solution in
methanol, very pale clear yellow
solution.
Solubility: Sparingly soluble in water;
soluble in ethanol (96%); slightly
soluble in ether.
Storage: Stored in airtight container
protected from light at room
temperature not exceeding 300c.
Therapeutic Category:
Adrenergicbeta-2 Receptor Agonists
Bronchodilator Agents
Tocolytic Agents

4. 1. Materials and Reagents:
Materials that were used throughout that experiments are listed below:
List of materials
SL. No Name Source Country
1 Salbutamol Local Market Bangladesh
2 Starch BDH U.K
3 Lactose BASF U.S.A
4 Crospovidone Local Market Bangladesh
5 Magnessium Stearate Local Market Bangladesh
6 Avicel pH 101 Local Market Bangladesh
7 Distilled Water Research Laboratory Bangladesh

5. 2. Equipments used in this Experiment:
List of Instruments and equipments that were used in that Experiments
Apparatus Model
USP Type II Dissolution Apparatus. Dissolution Rate Test Apparatus Two Stage
Intelli Series, India.
UV Spectrophotometer. UV- 1 600 PC Spectrophotometer, Mapada,
Korea.
Electronic Balance (AY120). Emark, Germany.
Pipette. China.
Beaker. China.
Slide calipers. China.
Hardness tester. Monsanto hardness tester, India.
Disintegration tester. Disintegration Test Apparatus, Single Unit,
India.
Friabilator. Friability test Apparatus (single drum), India.

6. Formulation of Salbutamol tablet using different disintegrating agent.
Ingredient Formula-1 Formula-2 Formula-3
Salbutamol 4 4 4
Lactose 31 41 51
Starch 20 20 20
Avicel pH 101 100 100 100
Magnessium Stearate 5 5 5
Crospovidone 40 30 20
Total amount 200 200 200

7. Measurement of some physical parameters of resulting
tablets
1. Diameter test
2. Thickness test
3. Weight Variation test
4. Hardness test
5. Friability test
6. Disintegration time
7. Dissolution test
8. Potency calculation

8. 1. Evaluation of different Physical and Chemical Properties of Salbutamol
tablets:
Comparison of Average Weight Variation, Diameter, Thickness, and Hardness with
Standard Deviation between various formulation ratios of Salbutamol tablets:
Formulation
code
Uniformity of
weight, mg
(mean ± sd)
Diameter(mm) ±
Standard
Deviation
Thickness(mm)
± Standard
Deviation
Hardness(kg/cm
2) ± Standard
Deviation
F1 200±0.2 9.5±0.0 2.8±0.001 3.1±0.1
F2 201±0.3 9.5±0.0 2.8±0.002 3.2 ±0.2
F3 202±0.3 9.5±0.0 2.8±0.001 4.4±0.5

9. 2. Friability Test of Salbutamol tablets:
Friability of various formulation of Salbutamol tablets.
Formulation code Friability % loss
F1 0.127
F2 0.119
F3 0.125

10. 3. Disintegration Test of Salbutamol tablets:
Disintegration time of various formulation of Salbutamol tablets.
Formulation code Time (Minute)
F1 2.5
F2 3
F3 3

11. 4. Dissolution profile of Salbutamol tablets:
Graphical representation of time vs. % drug release of all Formulations (F1,F2,F3).

12. 5. Potency Calculation Of Salbutamol Tablets:
Sample % Potency
1 94.31
2 95.09
3 93.65

13.  Formulation of immediate release salbutamol tablet can be optimum by
using different proportion of crospovidone as disintegrating agent.
 Further studies can be assessed further by conducting bioavailability
studies in human volunteers and long term stability testing.