Ch. 15 sterile dosage forms

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parenterals, injectables, sterile dosage forms, pyrogens, sterilization, sterilization by membrane filtration autoclave, parenteral routes

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  • The fastest route of paranteral drug adminsitration – INTRAVENOUS Aqueous solutions are preferred via this route - INTRAVENOUS Provide drug effect that is less rapid (delayed drug absorption), but generally longer lasting than the IV route – INTRAMUSCULAR Oleaginous solutions are preferred via this route – INTRAMUSCULAR Preferred route for injection of small amounts of medication –SUBCUTANEOUS Preferred route for immunization and desensitization tests on the skin – INTRADERMAL Administration of systemic anesthesia for CS delivery - INTRASPINAL
  • UTILIZES ETHYLENE OXIDE
  • Ch. 15 sterile dosage forms

    1. 1. Chapter 14: STERILE DOSAGE FORMSParenteralsBiologicalsIrrigation FluidsDialysis SolutionsPellets or ImplantsOphthalmic PreparationsBy:Asst. Prof. Ma. Lourdes L. Mojares, R. Ph.CEU School of PharmacyManila
    2. 2. INJECTIONS / INJECTABLESSterile, pyrogen-free preparations intended to be administered parenterally.. PARENTERAL – refers to injectable routes of administration. A route of administration OTHER THAN the oral route.
    3. 3. PARENTERALSCONSIDERATIONS inCOMPOUNDING:1. Sterile2. Pyrogen free3. Isotonic4. Prepared in environmentally controlled area5. Packaged in special hermetic container6. Use of colorants is strictly prohibited
    4. 4. PARENTERALSSTERILEAbsence of microorganismsPYROGENS / PYROGENESFever –producing organic substancesarising from microbial contaminationof a parenteral product.Usually produces fever-like reactions.
    5. 5. PARENTERAL ROUTESINTRA- Into the jointsARTICULARINTRASYNOVIAL Into the joint fluid areaINTRASPINAL Into the spinal columnINTRATHECAL Into the spinal fluidINTRA-ARTERIAL Into the arteriesINTRACARDIAC Into the heartINTRAVENOUS Into the veinINTRAMUSCULAR Into the muscle
    6. 6. PARENTERAL ROUTESINTRADERMAL Into the skinINTRACUTANEOUS Into the skinSUBCUTANOUS Under the skinHYPODERMIC Under the skin
    7. 7. OFFICIAL TYPES OF INJECTIONS TYPES EXAMPLE1. Injection Insulin Injection, USP2. For injection Cefuroxime for Injection, USP3. Injectable emulsion Profopol, USP4. Injectable suspension Methylprednisolone Acetate Suspension, USP5. For injectable suspension Imipenem and Cilastatin for Injectable Suspension, USP
    8. 8. SOLVENTS AND VEHICLE FOR INJECTIONSAQUEOUS NON-AQUEOUS Water for Injection, USP  Fixed vegetable oils Sterile Water for  corn oil, cottonseed oil, Injection, USP peanut oil, and sesame Bacteriostatic Water for oil Injection, USP  Glycerin Sodium Chloride  Polyethylene glycols Injection, USP  Propylene glycol Bacteriostatic Sodium  Alcohol Chloride Injection, USP Ringer’s Injection, USP Lactated Ringer’s Injection, USP
    9. 9. ADDED SUBSTANCES ANTIBACTERIAL PRESERVATIVES Added to parenteral products in multiple-dose container / packaging ONLY (vials). BUFFERS Act as pH stabilizers for pH –sensitive drugs. Helps resist changes in the pH of the product.
    10. 10. ADDED SUBSTANCES SOLUBILIZERS Aids in increasing solubility of the drug in the solvent system. ANTIOXIDANTS Protects the drug against degenerative changes brought about by oxidation.
    11. 11. METHODS OF STERILIZATION1. STEAM STERILIZATION Employs “steam under pressure” in an AUTOCLAVE. Uses 1210C at 15 psi for 20 minutes setting.2. DRY HEAT STERILIZATION Employs “convective heat” in OVENS. Less effective than steam sterilization. Uses 1500C to 1700C for hours.
    12. 12. AUTOCLAVES CONVECTION OVEN
    13. 13. METHODS OF STERILIZATION3. STERILIZATION BY FILTRATION Applicable to heat-labile parenterals. Involves removal of microorganisms by adsorption on a filter medium or by sieving mechanism. Uses a membrane filter or cellulose ester membrane filter.
    14. 14. MEMBRANE FILTER:
    15. 15. MEMBRANE FILTRATION SETUP:
    16. 16. METHODS OF STERILIZATION4. GAS STERILIZATION Applicable to sterile powders and plastic containers. The material is autoclaved first, then the gases are introduced. Uses the ff. sterilizing gases: Ethylene oxide Propylene oxide Beta-propiolactone
    17. 17. GAS STERILIZATION CHAMBERS
    18. 18. METHODS OF STERILIZATION5. STERILIZATION by IONIZING RADIATIONExposes the material toRADIATION – EMITTINGISOTOPES, such as; gamma rays cathode rays beta rays
    19. 19. GAS STERILIZATION CHAMBER
    20. 20. PACKAGING, LABELING AND STORAGE OF INJECTIONS CONTAINERS  Must not interact chemically or physically with the preparation  Either single- or multiple-dose containers  Single-dose package include ampuls, vials, and prefilled syringes  Types of glass containers are I, II and III.
    21. 21. LABELING Product title should be:  FOR LIQUIDS  Injection, Injectable Suspension, and Injectable Emulsion  FOR SOLIDS  For Injection  For Injectable suspension
    22. 22. SMALL VOLUME PARENTERALS Available in ampules, vials, or pre-filled syringes / pens. Package in single-dose or multiple-dose containers (2 mL to 30 mL)Examples:Heparin Sodium InjectionInsulin InjectionLidocaine HCl Injection
    23. 23. SMALL VOLUME PARENTERALS
    24. 24. LARGE VOLUME PARENTERALS Administered by intravenous infusion to replenish body fluids, electrolytes, or to provide nutrition Usually in volumes of 100 mL to 1 Liter Employed in maintenance therapy and replacement therapyExamples: Ringer’s Inj., Mannitol Inj., Sodium Chloride Inj., Dextrose Inj.
    25. 25. LAEGE VOLUME PARENTERALS
    26. 26. B OGICAL P IOL RODUCTS Sterile preparations that exert IMMUNOLOGIC EFFECTS to develop the immunity from a disease. Normallypackaged as small- volume parenterals.
    27. 27. B OGICAL P IOL RODUCTS Vaccines, Toxoids, Antitoxins, Immune Serum, Antivenins, Blood derivatives, Immunologic diagnostic aids. Stored in refrigerator (between 2°C and 8°C), or freezer with a temperature of -15°C.Examples: MMR Virus vaccine, Poliovirus vaccine, Tetanus toxoid, Tetanus antitoxin, Antivenin polyvalent, Smallpox vaccine, Typhoid vaccine
    28. 28. OPHTHALMIC PRODUCTS 1. Solutions 2. Suspension 3. Gels 4. Ointments 5. Drug impregnated inserts 6. Contact lenses 7. Contact lenses care products
    29. 29. Special considerations forophthalmic solutions andsuspensionsSterilityPreservationIsotonicityBufferingViscosityOcular bioavailabilityPackaging

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