STERILE DOSAGE FORMS

INJECTIONS:
- sterile, pyrogen limited(bacterial endotoxin Causes fever and is intended to be administered parenterally.
OFFICIAL TYPES OF INJECTION: 1. Injection - Liquid preparation that are drug substances or solutions thereof. 2. For injection - Dry solids that upon addition of suitable vehicles. 3. Injectable Emulsion - Liquid preparation of drug substances dissolved or dispersed in a suitable emulsion medium. 4. Injectable suspension - Liquid preparations of solid suspended in a suitable liquid medium. 5. For injectable suspension

Difference in preparing solutions and suspensions for injection with general solutions and disperse systems
Solvents and vehicles must be pure(free from impurities). The use of added substance such as Buffers, stabilizers, and antimicrobial preservatives fall under specific guidelines of use and are restricted in certain parenteral products. The use of Coloring is PROHIBITED. Should be sterilized, meet sterility standards and must be pyrogenfree. Parenteral solutions must meet compendial standards. Must be prepared in environmentally controlled areas. UNDER STRICT SANITATION STANDARDS. Packaged in Special hermetic containers. Container should be filled with excess(allowance). Volume of injection permitted in multiple dose containers is restricted Specific labelling regulations apply to injections. Sterile products are to be reconstituted prior to injection.

SOLVENTS AND VEHICLES FOR INJECTIONS

Water for injection - this is water purified by distillation or reverse osmosis. - Should be stored in tight containers at temperature above/below the range in which microbial growth occurs. - intended to be used within 24 hrs. After collection. - should be collected in sterile and pyrogenfree containers.

 Sterile water for injection - must be pyrogen-free but does have an allowable endotoxin level. - it may not contain antimicrobial agents or added substances. Bacteriostatic water for injection - sterile water for injection containing one or more antimicrobial agent. - packed in prefilled syringes or in vials containing not more than 30mL of the water. - This isn t to be used by NEONATES because it has BENZYL ALCOHOL which is toxic to them.

 Sodium Chloride injection - NaCl in water. - it contains no antimicrobial agent but has approx. 154mEqeach of sodium chloride ions/L. - NaCl injection is used as a catheter or IV line flush to maintain patency. Bacteriostatic Sodium Chloride injection - containing one or more antimicrobial agent. - is also used for catheter or IV line flush to maintain patency.

 Ringer s injection - is a sterile solution of NaCl, KCl, and CaCl in water for injection. - employed as a vehicle for other drugs or alone as an electrolyte replenisher and plasma volume expander. Lactated Ringer s injection - has a different qty of the 3 salts in ringer s inj. With an additional SODIUM LACTATE. - This injection is a fluid and electrolyte replenisher and systemic alkalizer.

 NONAQUEOUS VEHICLES - Fixed vegetable oils, glycerin, polyethylene glycols, propylene glycol, alcohol, and a number of less used agents including ethyl oleate, isopropyl myristate, and dimethyl acetamide. - Veg.Oils in parenteral products must remain clear when cooled to 10OC accdg. To USP. When employed in parenteral products, the label must state the specific oil.

-The most commonly used fixed oils in injections are CORN OIL, COTTONSEED OIL, PEANUT OIL, and SESAME OIL.CASTOR OIL and OLIVE OIL has been occassionally used. ADDED SUBSTANCES - Antimicrobial preservatives, buffers, solubilizers, antioxidants and other adjuncts. -COLOR IS PROHIBITED.

METHODS OF STERILIZATION - means destruction of all living organisms and their spores or their complete
removal from the preparation.

1. STEAM - is conducted in an autoclave(121OC under a 15lb pressure for 20mins.) and employs steam under pressure. 2. DRY-HEAT STERILIZATION - usually carried out in ovens 3. STERILIZATION BY FILTRATION - physical removal of microorganisms by adsorption on the filter medium or by a sieving mechanism. - used for sensitive heat solution.

4. GAS STERILIZATION - used for some heat-sensitive and moisture sensitive materials. Can be sterilized much more by exposure to ethylene oxide or propylene oxide gas. - usually employed in sterilization of medical and surgical supplies and appliances such as catheters, needles and plastic disposable syringes. 5. STERILIZATION BY IONIZING RADIATION - by the use of gamma rays and cathode rays.

PACKAGING, LABELING, AND STORAGE CONDITIONS

-Containers for injections, including the closures must not interact physically or chemically with the preparation so as to alter its strength or monograph. - Injections are placed in either Single-dose containers (Hermetic container intended for single administration only). May be ampuls/pre-filled syringe/single-dose vials. Multiple-dose containers (hermetic container that permits withdrawal of successive portions of the contents w/o changing the strength, quality, or purity of the remaining portion)

LARGE VOLUME PARENTERAL -employed in Maintenance therapy for the patient entering or recovering from surgery and for the patient who is unconscious and unable to take fluids, electrolytes and nutrition orally. - may also be used in Replacement therapy for patients who have suffered a heavy loss of fluid and electrolytes.

MAINTENANCE THERAPY
Total parenteral Nutrition- food for unconscious, depends on your calories/day. provides all of the essential nutrients to minimize tissue breakdown and to maintain normalcy within the body.

REPLACEMENT THERAPY
- When patient has undergone heavy loss of electrolyte and water, as in severe diarrhea, or vomiting, patients with crohn disease, AIDS, Burns, or trauma are candidates

IRRIGATION AND DIALYSIS SOLUTIONS

- IRRIGATION AND DIALYSIS SOLUTIONS are not injected into the vein but employed outside of the circulatory system. IRRIGATION SOLUTIONS - intended to bathe, or wash wounds, surgical incisions or body tissues.

DIALYSIS SOLUTIONS - Peritoneal dialysis solutions, allowed to flow into the peritoneal cavity, are used to remove toxic substances normally excreted by the kidney. - Hemodialysis is employed to remove toxins from the blood. Blood Out Machine(Filter) back to blood stream

BIOLOGICALS- vaccines(immunizing agents)

BIOLOGICALS - substance produced by a living source; biologics include antibiotics, hormones, and vitamins. - vaccines(immunizing agents) - Must be stored in Refrigerator temperatures(2-8OC), and freezers should stay well below 0OC.Usually, an optimal temperature is -15OC.

OPTHALMIC PRODUCTS
Solutions Suspensions Gels Ointments Implant Contact lens

PHARMACOLOGIC CATEGORIES OF OPHTHALMIC DRUGS 1. Anesthetics 2. Antibiotic and antimicrobial 3. Antifungal 4. Anti-inflammatory 5. Antiviral 6. Astringent 7. Beta adrenergic blocking agents 8. Miotics(Constrict pupil) and other glaucoma agents 9. Mydriatics(Dilate pupil) 10. Protectants and artificial tears 11. Vasoconstrictors(Remove redding of the veins of the eye)

PHARMACEUTICAL REQUIREMENTS
Sterility preservation(must be sterilized for safety) Isotonicity value Buffering -The pH of an ophthalmic preparation may be adjusted and buffered for one or more of the following purposes. 1. For greater comfort 2. Render formulation stability 3. Enhance aqueous solubility of the drug 4. Enhance drugs bioavailability 5. Maximize preservative efficacy

 Viscosity and Thickening agents - thickening agent is frequently added to increase the viscosity and thereby aid in maintaining the drug in contact with the tissue to enhance therapeutic effectiveness. - HYDROXYPROPYL METHYLCELLULOSE and POLYVINYL ALCOHOL are used as thickeners in ophthalmic solutions.
Particle size of suspension should be very micro to prevent corneal irritation.

 Ocular bioavailability Packaging ophthalmic solutions and suspensions - usually packed in small glass bottles with separate glass or plastic droppers, most are packed in soft plastic containers with a fixed built-in dropper.

NASAL PREPARATIONS
PRODUCT Afrin Nasal spray/ nasal drops Beconase AQ nasal spray Diapid nasal spray Nasalide Ocean mist/ salinase INDICATION/s Decongestant Perennial allergic, vasomotor rhinitis antidiuretic Perennial rhinitis Restore moisture, relieve dry ,crusted,inflamed nasal membranes decongestant oxytocin

Privine HCl nasal solution Syntocinon nasal spray