Ch. 15 sterile dosage forms
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Chapter 14 discusses sterile dosage forms, focusing on parenterals, biologicals, and ophthalmic preparations. It outlines the requirements for compounding parenterals, various injection types, methods of sterilization, and storage and labeling practices. Special considerations are also provided for biological products and ophthalmic formulations.
Ch. 15 sterile dosage forms
- 1. Chapter 14: STERILE DOSAGE FORMS Parenterals Biologicals Irrigation Fluids Dialysis Solutions Pellets or Implants Ophthalmic Preparations By: Asst. Prof. Ma. Lourdes L. Mojares, R. Ph. CEU School of Pharmacy Manila
- 2. INJECTIONS / INJECTABLES Sterile, 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. PARENTERALS CONSIDERATIONS inCOMPOUNDING: 1. Sterile 2. Pyrogen free 3. Isotonic 4. Prepared in environmentally controlled area 5. Packaged in special hermetic container 6. Use of colorants is strictly prohibited
- 4. PARENTERALS STERILE Absence of microorganisms PYROGENS / PYROGENES Fever –producing organic substances arising from microbial contamination of a parenteral product. Usually produces fever-like reactions.
- 5. PARENTERAL ROUTES INTRA- Into the joints ARTICULAR INTRASYNOVIAL Into the joint fluid area INTRASPINAL Into the spinal column INTRATHECAL Into the spinal fluid INTRA-ARTERIAL Into the arteries INTRACARDIAC Into the heart INTRAVENOUS Into the vein INTRAMUSCULAR Into the muscle
- 6. PARENTERAL ROUTES INTRADERMAL Into the skin INTRACUTANEOUS Into the skin SUBCUTANOUS Under the skin HYPODERMIC Under the skin
- 7. OFFICIAL TYPES OF INJECTIONS TYPES EXAMPLE 1. Injection Insulin Injection, USP 2. For injection Cefuroxime for Injection, USP 3. Injectable emulsion Profopol, USP 4. Injectable suspension Methylprednisolone Acetate Suspension, USP 5. For injectable suspension Imipenem and Cilastatin for Injectable Suspension, USP
- 8. SOLVENTS AND VEHICLE FOR INJECTIONS AQUEOUS 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. 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. 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. METHODS OF STERILIZATION 1. 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. AUTOCLAVES CONVECTION OVEN
- 13. METHODS OF STERILIZATION 3. 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. MEMBRANE FILTER:
- 16. METHODS OF STERILIZATION 4. 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
- 18. METHODS OF STERILIZATION 5. STERILIZATION by IONIZING RADIATION Exposes the material to RADIATION – EMITTING ISOTOPES, such as; gamma rays cathode rays beta rays
- 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. LABELING Product title should be: FOR LIQUIDS Injection, Injectable Suspension, and Injectable Emulsion FOR SOLIDS For Injection For Injectable suspension
- 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
- 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 therapy Examples: Ringer’s Inj., Mannitol Inj., Sodium Chloride Inj., Dextrose Inj.
- 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. 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. OPHTHALMIC PRODUCTS 1. Solutions 2. Suspension 3. Gels 4. Ointments 5. Drug impregnated inserts 6. Contact lenses 7. Contact lenses care products
- 29. Special considerations for ophthalmic solutions and suspensions Sterility Preservation Isotonicity Buffering Viscosity Ocular bioavailability Packaging
Editor's Notes
- #6: 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
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