Parenteral Preparation PDF

PARENTERAL PREPARATION  PARENTERALS Para: outside Enteron: intestine These are the preparation which are given other than oral routes. Injections: These are: Sterile. Pyrogen free preparations intended to be administrate parenterally (outside alimentary t...

PARENTERAL PREPARATION  PARENTERALS Para: outside Enteron: intestine These are the preparation which are given other than oral routes. Injections: These are: Sterile. Pyrogen free preparations intended to be administrate parenterally (outside alimentary tract).  Why parenteral? Parenteral route is used because 1) Rapid action 2) Oral route can not be used 3) Not effective except as injection 4) Many new drug particularly those derived from new development in biotechnologically can only be given by parenteral as they are inactivated in GIT if given orally. 5) New drugs require to maintain potency & specificity so that they are given by parenteral.  Advantages: - Quick onset of action. - Suitable for the drugs which are not administered by oral route. - Useful for unconscious or vomiting patients. - Duration of action can be prolonged by modifying formulation. - Suitable for nutritive like glucose & electrolyte. - Suitable for the drugs which are inactivated in GIT or HCL (GI fluid). - Bypass hepatic first pass effect.  Necessities of parenteral preparation: - Sterility (must) - Free from pyrogen (must) - Free from particulate matter (must) - Clarity (must) - Stability (must) - Isotonicity (should) - Solvents or vehicles used must meet special purity and other standards. - Restrictions on buffers, stabilizing, antimicrobial preservative. Do not use coloring agents. - Must be prepared under aseptic conditions. - Specific and high quality packaging Parenteral route of administration: Most common: 1. Subcutaneous (SC, SQ, sub Q) 2. Intermuscular (IM) 3. Intravenous (IV) Others: 4. Intra-arterial (IA) 5. Intrathecal 6. Intraarticular 7. Intrapleural 8. Intracardial 9. Intradermal (Diagnostic)  Subcutaneous (SC, SQ, sub Q): - The injection is given under the skin. - Need to be isotonic. - Upto 2 ml is given Given: - Vaccines - Insulin - Scopolamine - Epinephrine  Intramuscular (IM) - Striated muscle fibre - 0.5 to 2 ml sometimes upto 4 ml - Preferably isotonic - Can be use for delay or prolonged effect by: a. administration of the drug in suspension form b. use of oil vehicle Principle sites: - Glureal (buttocks), Deltoid (upper arms) and Vastus lateralis (lateral thigh) Given: - Solutions - Emulsions - Oils - Suspension  Intravenous (IV): - Into the vein. - 1 to 1000 ml. - Injection rate of 1ml/10 sec. give rapid effect. - Need trained person in administration. Given: - Aqueous solutions - Hydro alcoholic solution - Emulsions - Liposome  Intra-arterial (IA): - Direct into the artery. - 2 to 20 ml. - There effect is mainly localized rather than generalized ad in I.V. - Mostly used for diagnostic purposes such as arteriogram and also for anti-neoplastic drugs. - Solution & emulsions can be administered. Given: - Radio opaque media - Antineoplastic  Intrathecal: - Also called inta-spinal. - Directly given into the spinal cord - 1 to 4 ml. - Must be isotonic. Given: - Local anesthetic (LA) - Analgesics - Neuroleptics Intra- articular: - Inside the joints - Used for corticosteroids and LA  Intradermal: - Also called as diagnostic testing. - 0.05 ml. - Should be isotonic Given: - Diagnostic agents  Types of parenteral preparation They can classified according to: 1. Type of packaging: 1. Single dose units (ampoules, pre-filled disposable syringes) 2. Infusion solution 3. Multiple dose units (vials) 2. Volume: 4. Small volume parenteral (SMP) of less than 100 ml. 5. Large volume parenteral (LVP) of 100 ml or more.  FORMULATION OF PARENTERAL Aqueous solvents: The preferred vehicle is water as it is well tolerated by the body and easy to administer. Water for injection (WFI) Sterile Water for injection (SWFI). Bacteriostatic Water for injection (BMFI) Sodium chloride injection (USP) Sterile water for inhalation. Sterile water for irrigation.  FORMULATION OF PARENTERAL 1. Water for injection (WFI): It is the water intended to be used in the manufacture of injectable products, which are to be sterilized after their preparation. It is the most frequently used solvent. It contains no added substances. It is NOT used for the dilution of packaged parenteral products. Although it is not required to be sterile, it should be free from pyrogens. It must be clear, colorless and odorless. Prepared by distillation or reverse osmosis  FORMULATION OF PARENTERAL 2. Steriel Water for injection (SWFI): Sterile Water for injection (USP) is a sterile, non-pyrogenic preparation of water for injection which contains no antimicrobial agent or added buffer and is supplied only in single-dose containers Uses: used to dilute or dissolve already-sterilized and packaged injectable medications such as the dry powders of Na. It is added under aseptic conditions.  FORMULATION OF PARENTERAL 3. Bacteriostatic Water for injection (BWFI): Bacteriostatic water for injection (USP) is a sterile, non-pyrogenic preparation of water for injection containing 0.9% (9mg/ml) of benzyl alcohol added as a preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The PH is 5.7 (4.5 to 7.0).  FORMULATION OF PARENTERAL 3. Bacteriostatic Water for injection (BWFI): N.B. if the patient will receive more than 5ml of parenteral preparation, BWFI is not the vehicle of choice. Why? To avoid excessive and/or toxic concentration of antimicrobial agent(s) which would be injected along with the medication. N.B the added bacteriostatic(s) should be compatible (doesn’t interact) with the drug.  FORMULATION OF PARENTERAL 4. Sodium chloride injection (USP): Is a sterile isotonic solution of NaCl in water for injection. Contains no antimicrobial agent. May be used as a sterile vehicle in solutions or suspensions of drugs for parenteral administration.  FORMULATION OF PARENTERAL preservatives: multidose containers must have preservatives unless prohibited by monograph. Large volume parenterals (LVP) must not contain preservative because it may be dangerous to human body if it contain in high dose. Tonicity – adjusting agents: Osmolarity adjustment is mode usually by using sodium chloride, glucose or mannitol using one of the following methods: - The freezing point depression method - Sodium chloride equivalent - Examples: Mannitol, Dextrose, Sodium chloride, Sorbitol, Boric acid  Total parenteral Nutrition TPN stands for total parenteral Nutrition. This is a complete form of nutrition, containing protein, sugar, fat and added vitamins and minerals as needed for each individual. Total parenteral Nutrition (TPN) may be defined as provision of nutrition for metabolic requirements and growth through the parenteral route. (intravenous Nutrition) - They are available as ready-to-mix kits. - Parenteral nutrition (PN) can be used to supplement ordinary or tube feeding  Nutritional Requirements - Amino acids - Glucose - Lipid - Minerals - Vitamins - Water and electrolytes - Trace elements  Why it is necessary? TPN might be necessary if: - A patient is severely undernourished, and needs to have surgery, radiotherapy or chemotherapy. - A patient suffers from chronic diarrhea and vomiting. - A baby’s gut is too immature. - A patient’s (their “gastrointestinal tract”) is paralysed, for example after major surgery.  PACKAGING OF PARENTERAL A. Single dose container Glass ampoules are the most commonly used single dose containers and can range from size of 1 to 50ml Ampules  PACKAGING OF PARENTERAL B. Multiple dose container A hermetic container that permits withdrawal of successive portions of contents without changing the strength, quality or purity of the remaining portion. Parenterals - examples Parenterals - examples Parenterals - examples Parenterals - examples Parenterals - examples