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Formulation & In vitro Evolution of Immediate Release of Salbutamol.ppt

suzon ali
30 de Mar de 2023
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Formulation & In vitro Evolution of Immediate Release of Salbutamol.ppt

  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.
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