Synopsis mule


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Synopsis mule

  1. 1. Seminar On Synopsis For M.Pharm Dissertation By MULE MADHAV SHESHERAO Under the Guidance of Guide Mr. Kshirsagar R. V. Asst. Professor School of pharmacy SRTMU Nanded Industrial Guide Mr. N. K. Shinde Senior Executive Lupin Research Park School of Pharmacy, SRTMU, Nanded .
  2. 2. <ul><li>The period between 1950 to 1970 is considered as period of Sustained drug release . </li></ul><ul><li>The main AIM of preparing sustained release matrix tablet is intended to modify and improve the drug performance by, </li></ul><ul><ul><li>Increasing the duration of drug action and Absorption. </li></ul></ul><ul><ul><li>Avoid the fluctuation of plasma drug concentration. </li></ul></ul><ul><ul><li>Decreasing the frequency of dosing. </li></ul></ul><ul><ul><li>Decreasing the required dose employed. </li></ul></ul>
  3. 3. <ul><li>SR matrix tablet describes the slow release over extended period of time. </li></ul><ul><li>The various type of matrices </li></ul><ul><li>Slow Eroding Matrix </li></ul><ul><li>Hydrophilic Matrix </li></ul><ul><li>Plastic Matrix </li></ul>
  4. 4. <ul><li>Improved patient compliance : </li></ul><ul><ul><li>Less frequent dosing </li></ul></ul><ul><li>Decreased local and systemic side effects . </li></ul><ul><ul><li>Decreased GIT irritation. </li></ul></ul><ul><ul><li>Decreased local inflammation. </li></ul></ul><ul><li>Better drug utilisation . </li></ul><ul><ul><li>Decreased total amount of drug used. </li></ul></ul><ul><ul><li>Minimum drug accumulation on chronic dosing. </li></ul></ul><ul><li>Improved efficiency in treatment . </li></ul><ul><ul><li>Uniform blood and plasma concentration. </li></ul></ul><ul><ul><li>Decreased fluctuation in drug level </li></ul></ul><ul><ul><li>Increased bioavailability of some drugs </li></ul></ul>
  5. 5. <ul><ul><ul><li>Dose Dumping : Increase quantity of drug release causes dumping of drug which in turn leads to toxicity. </li></ul></ul></ul><ul><ul><ul><li>Reduced Potential For Accurate Dose Adjustment : Administrating a fraction of drug is not possible. </li></ul></ul></ul><ul><ul><ul><li>Need For Additional Patient Education : </li></ul></ul></ul><ul><ul><ul><li>“ Do not Crush or Chew the dosage unit”. </li></ul></ul></ul><ul><ul><ul><li>“ Tablet residue may appear in stools”. </li></ul></ul></ul>
  6. 6. Antidepressant drug is used orally for the treatment of patients with depression, caused by chemical imbalance on any other reasons. One of the major problems of this drug is its very poor biological half life (4hrs), which results in poor bioavailability after oral administration. Antidepressant drug and its active metabolite inhibit the neuronal uptake of norepinephrine, serotonin and to a lesser extent dopamine . Hence it lacks the adverse anticholinergic, sedative and cardiovascular effects of tricyclic antidepressants. It also requires low dose and it has less dopamine reuptake activity as compared to other antidepressant drug.
  7. 7. <ul><li>To increase the Half life and bioavailability of antidepressant drug. </li></ul><ul><li>To provide a sustained release formulation of freely water soluble drugs. </li></ul><ul><li>To provide a sustained release formulation capable of delivering the drug substance within 24 hours. </li></ul><ul><li>To decrease side effect which shown by other antidepressant drug. </li></ul>
  8. 8. <ul><li>Literature survey. </li></ul><ul><li>Selection of drug and Initial Studies of Marketed Product Characterization and Selection of Excipients. </li></ul><ul><li>Drug excipients compatibility studies. </li></ul><ul><li>Preparation of trial formulation for in vitro evaluation. </li></ul><ul><li>Evaluation of trial formulation for every stage of manufacturing viz- Mixing, blending, compression etc. </li></ul><ul><li>Evaluation of tablet </li></ul><ul><li>Stability studies of optimized formulation. </li></ul><ul><li>Scale-Up and Optimisation Trials towards Commercial Batches. </li></ul><ul><li>Interpretation of results and Thesis Submission. </li></ul>
  9. 9. Margret Chandra et al, (2009): “formulation and evaluation of sustained release matrix tablets of zidovudine”. By using Kollidon SR, Hydroxypropyl methylcellulose K15M, K100M as matrix former. Punit B. Parejiya et al, (2010): “Development and Characterization of Once a Daily Tablet Formulation of Aceclofenac” Matrix tablets were prepared by direct compression of Kollidon SR varying proportion with fixed percentage of aceclofenac. MD. Selim Reza et al, (2008): “Development of Theophylline Sustained Release Dosage Form Based on Kollidon SR” Four matrix tablet formulations were prepared by dry blending and direct compression of Kollidon SR and HPMC-15cps. Walid Sakr et al, (2009) Effect of Kollidon SR on the release of Albuterol Sulphate from matrix tablets evaluate Kollidon SR for the development of extended release Albuterol Sulphate matrix tablets.
  10. 10. <ul><li>Drug Candidate : Antidepressant drug </li></ul><ul><li>Excipients </li></ul><ul><li> Silica colloidal anhydrous , Magnesium stearate, Calcium hydrogen phosphate dehydrate, Kollidon SR, Macrogol 6000, Titanium Dioxide, Talcum, Ammonium methacrylate copolymer dispersion(Eudragit RS 30D) </li></ul><ul><li>Solvents: Distilled Water. </li></ul><ul><li>Preparation of sustained release matrix tablet by direct compression Method. </li></ul>
  11. 11. Sr no Parameter Description 1 Category Antidepressant 2 Solubility 572mgml of water 3 Half life 5 hour 4 Mol. Wt. 313.87 5 pka 0.43 6 Dose 75 mgday 7 Bioavailibility 45%
  12. 12. 1. Pre-compression Parameter . a) Bulk density b) Tapped density c) Compressibility Index and Hausner’s Ratio d) Angle of repose (θ) 2. Post- compression parameters. a) Weight variation b) Disintegration Test c) Friability d) Hardness and Thickness e) Dissolution Study f) Assay
  13. 13. <ul><li>Simona JS, Aguiar LM. Extended Release Venlafaxine in Relapse Prevention for Patients with Major Depressive Disorders, J Psychiatr Res. 38, 2004, 249-257. </li></ul><ul><li>Troy S.M, Parker VD, Fruncillo RJ, Chiang ST, the Pharmacokinetics of Venlafaxine When Given in a Twicedaily Regimen. J Clin Pharmacol. 35, 1995, 404-409. </li></ul><ul><li>Gohel M.C,Bariya S.H.,“Fabrication of triple layer tablet of venlafaxine Hcl using xanthum gum”AAPS PharmSciTech, june2009,10 (2);624-630. </li></ul><ul><li>Holliday SM, Benfield P. Venlafaxine: A review of its pharmacology and therapeutic potential in depression drugs. Drugs. 1995;49:280–94. </li></ul><ul><li>Haskins JT, Moyer JA, Muth EA, Sigg EB. Inhibition of noradrenergic neuronal activity by the novel bicyclic compounds, Wy-45,030 and Wy-45,881. Soc Neurosci Abstr. 1984;10:262. </li></ul><ul><li>Acute effectiveness of additional drugs to the standard treatment of depression. Available from: [Last retrieved on 2005 June 23].   </li></ul><ul><li>Antidepressant discontinuation reactions. British Medical Journal (1998) 316: 1105-1106 (11 April). </li></ul><ul><li>Antidepressant drugs and generic counselling for treatment of major depression in primary care: randomised trial with patient preference. British Medical Journal (2001) 322: 772 (31 March). </li></ul>