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Microspheres

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Nirupama K vStudent at Bharathi College of Pharmacy

microspheres,types, advantages and disadvantages,methods of preparation, evaluation or characterization of microspheres and applications of microspheres in various pharmaceutical fields.

Microspheres

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MICROSPHERES
Presented by:
Nirupama K V
II M Pharm (P. Ceutics)
BCP. Bharathinagara
As a Drug Delivery System
CONTENTS:
INTRODUCTION.
TYPES OF MICROSPHERES.
ADVANTAGES AND DISADVANTAGES.
POLYMERS USED IN THE PREPARATION OF MICROSPHERES.
METHODS OF PREPARATION.
CHARACTERIZATION (Evaluation).
APPLICATIONS.
CONCLUSION.
REFERENCES
INTRODUCTION:
o Oral route of administration.
o Conventional drug delivery system frequent administration.
o Significant fluctuation in drug levels.
o Novel drug delivery system.
o Sustained and controlled release .
Definition of microspheres:
• Micro-particles or microspheres small, insoluble, free flowing spherical
particles.
• Size -10 to 1000 µm.
• Ideally, completely spherical and homogeneous in size.
• Polymers or proteins biodegradable .
• Drug dispersed or dissolved controlled release of the drug.
• Prolonged release & targeting.
Types of Microspheres:
• Microcapsule: An encapsulated core particle .
• Micromatrix (Mcrospheres): Homogenous dispersion.
Types of Microspheres:

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Microspheres

  • 1. MICROSPHERES Presented by: Nirupama K V II M Pharm (P. Ceutics) BCP. Bharathinagara As a Drug Delivery System
  • 2. CONTENTS: INTRODUCTION. TYPES OF MICROSPHERES. ADVANTAGES AND DISADVANTAGES. POLYMERS USED IN THE PREPARATION OF MICROSPHERES. METHODS OF PREPARATION. CHARACTERIZATION (Evaluation). APPLICATIONS. CONCLUSION. REFERENCES
  • 3. INTRODUCTION: o Oral route of administration. o Conventional drug delivery system frequent administration. o Significant fluctuation in drug levels. o Novel drug delivery system. o Sustained and controlled release .
  • 4. Definition of microspheres: • Micro-particles or microspheres small, insoluble, free flowing spherical particles. • Size -10 to 1000 µm. • Ideally, completely spherical and homogeneous in size.
  • 5. • Polymers or proteins biodegradable . • Drug dispersed or dissolved controlled release of the drug. • Prolonged release & targeting.
  • 6. Types of Microspheres: • Microcapsule: An encapsulated core particle . • Micromatrix (Mcrospheres): Homogenous dispersion. Types of Microspheres:
  • 7. ADVANTAGES: • Sustained and Controlled release . • Patient compliance is increased. • Toxic effect is less. • Targeting the tissue is possible. • Improve bioavailability. • They enable controlled release of drug. Ex: narcotic, antagonist, steroid hormones. • Protect the drug from enzymatic and photolytic cleavage so it is best for drug delivery of protein.
  • 8. DISADVANTAGES: • The cost is more. • Reproducibility is less. • Stability may affected by process conditions. • Degradation of product. • Intended mainly for parenteral route which causes pain. • Polymer may produce toxic effects
  • 9. Polymers used in the Microsphere preparation: Synthetic Polymers Non-biodegradable • PMMA(Poly methyl Methacrylate). • Acrolein • Epoxy polymers • Glycidyl methacrylate Biodegradable • Lactides and Glycolides copolymers • Polyalkyl cyanoacrylates • Polyanhydrides
  • 10. Natural Materials Proteins • Albumins • Gelatin • Collagen Carbohydrates • Starch agarose • Carrageenan • Chitosan Chemically modified carbohydrates • Poly(acryl)dextran • Poly(acryl)starch
  • 11.  Emulsion solvent evaporation technique. -Single emulsion method -Double emulsion method.  Emulsion cross linking method.  Coacervation method.  Spray drying and Spray Congealing technique.  Solvent Extraction technique.  Ionic gelation.  Solvent evaporation method: METHODS OF PREPARATION:
  • 12. Emulsion solvent evaporation technique: A. Single Emulsion Technique: Aq solution & suspension of polymer(natural polymer) Stirring / Sonication Dispersion in Organic phase oil/CHCl3 Heat denaturation (by adding Chemical crosslinking dispersion To heated oil). (Butanol, HCHO, Glutaraldehyde)
  • 13. . Microspheres in org.phase Centrifugation, washing, & separation Microspheres
  • 14. B. Double Emulsion Technique: Aqueous solution of polymer & drug dispersion in oil/organic phase, vigorous homogenisation(sonication) Primary emulsion(w/o) addition of aqueous solution of PVA W/O/W multiple emulsion Addition of large aqu. phase Microspheres in solution Separation, washing, drying MICROSPHERES.
  • 15. SPRAY DRYING AND SPRAY CONGEALING: Polymer dissolved in organic phase (acetone) Drug is dispersed in polymer solution under high speed homogenization Atomized in a stream of hot air Formation of small droplets Solvent evaporation Microspheres
  • 16. Separated by cyclone separator and traces of solvent is removed by vacuum drying
  • 17. SOLVENT EXTRACTION METHOD: Organic phase is removed by extraction with water Polymer in organic solvent Drug is dispersed in organic solvent (water miscible organic solvents like isopropanol) MICROSPHERES.
  • 18. SOLVENT EVAPORATION METHOD: Suitable amounts of polymer(Eudragit) + chloroform solution of the drug. The aqueous phase (0.2% PVA (Polyvinyl alcohol) in water). The mixture was stirred with a propeller at 500 rpm for 3 hrs at 250C. For complete removal of chloroform. Filtration & collection. Washed with deionized water. Microspheres dried at room temperature for 24 hrs.
  • 19. IONIC GELATION METHOD: Sodium alginate is dissolved in distilled water. stirred + drug & calcium carbonate (1:1). Gelation medium (calcium chloride in 2% glacial acetic acid)(21G syringe needle) . The gel microspheres formed in solution. Stirred for 30 min at room temperature. Then microsphere is collected, washed, dried & stored in desicator.
  • 20. Evaluation of Microspheres: • Drug content. • Drug entrapment efficiency. • Particle size analysis. • Surface morphology. • Angle of repose, Bulk density and Tapped density. • In vitro release. • Kinetic modeling. • Stability studies as per ICH guidelines.
  • 21. EVALUATION OF MICROSPHERES: 1) Drug content: UV Spectrometer. 2) Drug entrapment efficiency: % Entrapment = Actual content / Theoretical content x 100. 3) Particle size : Compound microscope, (Stage micrometer and Eye piece micrometer).
  • 22. 4) Surface morphology: Scanning Electron Microscope (SEM). 5) Angle of repose: Funnel method (Cone method). tan θ =h/r Where h & r are the height and radius of the powder cone.
  • 23. 6)Bulk density: Bulk density = mass of microspheres / bulk volume. 7)Tapped density: Tapped density = mass of microspheres /Tapped volume.
  • 24. 8) In vitro methods:  United States of Pharmacopeia (USP) dissolution apparatus II.  Phosphate buffer.  Rotating paddle apparatus. 9) Kinetic modeling: a) Zero order kinetics: Qt = Qo + Ko t Where, Qt = Amount of drug dissolved in time t, Qo = Initial amount of drug in the solution and Ko = Zero order release constant
  • 25. b) First order kinetics: log Qt = log Qo + K1t / 2.303 Where, Qt = Amount of drug released in time t, Qo = Initial amount of drug in the solution and K1 = First order release constant c) Higuchi model: Qt = KH.t ½ Where, Qt = Amount of drug released in time t and, KH = Higuchi dissolution constant.
  • 26. d) Korsmeyer - peppas release model: Mt/M∞ = K.tn Where, Mt / M∞ = Fraction of drug release, K= Release constant, t = Drug release time and n = Diffusional exponent for the drug release that is dependent on the shape of the matrix dosage form.
  • 27. 10) Stability Studies: • A stability study as per (ICH) guidelines. • Accelerated Stability testing studies 6 months. • Temperature 40 ± 2 ℃ and 75 ± 5 % RH. • At the end of 1,3&6 months % entrapment & Drug release (Physical parameters).
  • 28. APPLICATIONS:  Ophthalmic Drug Delivery  Oral drug delivery  Gene delivery  Nasal drug delivery  Buccal drug delivery  Gastrointestinal drug delivery  Transdermal drug delivery  Colonic drug delivery
  • 29. OTHER APPLICATIONS: • Diagnosis for ex; thermographic detection of tumours. • Biotechnology industry. • Culturing of a feline breast tumor line. • Haemoperfusion.
  • 30. CONCLUSION: • Controlled and sustained delivery. • Drug targeting. • Taste masking. • Aqueous solubility & absorption. • Improved Stability. • This area of novel drug delivery has innumerable applications and there is a need for more research to be done in this area.
  • 31. REFERENCES: 1. Metkari V.B, Kulkarni L.B, Patil P.S, Jadhav P.A, Bamane G.S, Kumbhar C.M. Microspheres - A New Drug Delivery System: A Review. Journal of Current Pharma Research 2014;4(2):1128-1133. 2. Pratibha Muntha. Microspheres - Novel Drug Carriers. Journal of Pharmacy and Pharmaceutical Sciences. 2014;3(3):83-86. 3. Kadam N. R., Suvarna V. Microspheres: A Brief Review. Asian Journal of Biomedical and Pharmaceutical Sciences. 2015;5(47):13-19. 4. Chitra Singh, Suresh Purohit, Madhu Singh , Pandey B.L. Design and evaluation of microspheres: a review. Journal of drug delivery research. 2013;2(2):18-27.
  • 32. cont….. 5. Nisha Sharma , Neha Purwar , Prakash Chandra Gupta. Microspheres as drug carriers for controlled drug delivery: a review. International Journal of Pharmaceutical Sciences and Research IJPSR, 2015;6(11):4579- 4587. 6. S.P.Vyas., R.K.Khar, International Journal for Targeted & Controlled Drug Delivery, Novel Carrier Systems., First Edition :2002.,Reprint :2007 page no:417,453. 7. N.K.Jain ,Controlled and novel drug delivery edited by reprint 2007 pg.no.236- 255.
  • 33. …..