UNIT- 4 (PARENTERAL PRODUCTS).pptx

Arun

1. PARENTERAL PRODUCTS

2. DEFINITION TYPES ADVANTAGES & DISADVANTAGES PREFORMULATION FACTORS ESSENTIAL REQUIREMENTS

3. INTRODUCTION DEFINITION : The term parenteral has been derived from greek word PARA ENTERON - outside the intestine . Parenterals are sterile preparations intended for administration under or through one or more layers of skin or mucous memberane .

4. TYPES BASED ON FORMULATION INJECTIONS : It contains sterile solutions and prepared by dissolving the active ingredient and other substances in water for injection or other suitable non aqueous base . INFUSIONS : These preparation are free from bacterial endotoxins or pyrogens and are turned isotonic with blood.

5. POWDER FOR INJECTION : These are solid compounds that are distributed in their final volume when container or vital are shaken to form a clear particle . CONCENTRATED SOLUTION FOR INJECTION : These are diluted with water for injection before injected through IV route . IMPLANTS : The solid sterile preparations are implanted in the tissue in order to release the active ingredient for long periods .

6. BASED ON DOSE SINGLE DOSE PREPARATIONS : These can be used only once . Contains sufficient quantity. Administration of volume specified on the label MULTI DOSE PREPARATIONS : Multi dosing , chances of contamination is less because it contains antimicrobial preservative in appropriate conc. Preservative not exceed than 30ml .

7. ADVANTAGES They are free from pyrogens . Low toxicity as compared to solid dosage forms . 100% Bioavailability . No chance of missing dose . Unconcious patients are also administered by physician .

8. DISADVANTAGES High cost as compared to solid dosage form . Requirement of trained person for administration Highly risk if any mistakes happens at any point. Real or physiological pain associated while inject

9. Essential requirements vehicles additives isotonicity

10. * Vehicles Aqueous vehicle : Water for injection : Most commonly used solvent in large scale manufacturing. Not sterilized and free from pyrogens . It is intended to be used within 24hrs after collection . Total solid contents not more than 1mg/100ml .

11. Sterile water for injection : It must be pyrogen free . Endotoxin level is not more than 0.25 USP . Single dose container not larger than 1 liter . Bacteriostatic water for injection : One or more suitable antimicrobial agents . It is packaged in prefilled syringes or in vials . Not more than 30 ml of water .

12. Non –Aqueous vehicle : They should be ., Non-irritant . Non-toxic . Pharmacologically inert . Non- senstising . Metabolise easily . Less viscous to allow syringability . eg : ethyl oleate , isopropyl myristate , benzyl benzoate , dimethylacetamide

13. ADDITIVES Solubilizing agents : Maintain the solubility of slightly soluble drugs by increasing their solubility . ( EX ; polysorbates , PEG 40 , ethanol ) Anti-oxidants : The substances that act against oxidants . (EX ; thiourea , ascorbic acid )

14. Buffering agents : Formulations must be maintain the intended Ph. ( Eg ; acetone ,citrate ,phosphate ) Antimicrobial agents : Used for prevention of microbes in multiple packaging . ( Eg ; phenol or chlorobutanol ) Chelating agents : Form complexes with the metal ion and dissolve in the solvent , thus preventing the metal ion from interferring in the manufacturing process . ( Eg ; EDTA )

15. IMPORTANCE OF ISOTONICITY It is important because if the solution is isotonic with blood , the possibility of the product penetrating the RBC’s and causing hemolysis is reduced . In hypotonic solution ( 0.2% w/v of NaCl ), water diffuses into the RBC’s causing swell and burst i.e., hemolysis . In hypertonic solution ( 2 % w/v of NaCl ), water diffuses out of RBC’s causing them to shrink . In isotonic solution ( 0.9 % w/v of NaCl solution), that maintains their tonicity of RBC .

16. THANK YOU