PARENTERALS

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PARENTERAL PRODUCTS:

PARENTERAL PRODUCTS PREPARED BY Dr. Deepak Sahu

para = besides enteron = intestine:

para = besides enteron = intestine

PowerPoint Presentation:

ROUTES OF ADMINISTRATION 1. Intradermal or Intracutaneous route (skin) DIAGNOSIS 2. Subcutaneous route (beneath the skin) 3. Intramuscular route ( deltoid & gluteous maximus ) 4. Intravenous route ( vein ) 5. Intra arterial route ( immediate action ) 6. Intra cardiac route ( in heart epinephrine ) 7. Intra thecal route ( into spinal cord ) 8. Intra cisteronal route ( between cerebellum & M.O. ) 9. Intra articular route (joint) 10. Intra synovial route (joint fluid area) 11. Intra peritoneal route 12. Intra pleural route ( lung for fluid withdrawal ) 13. Intraosseous (bone) 14. Intra epidural route (into epidural space near spinal column ) 15. Ophthalmic route 16. Intra lymphatic route

PRIMARY PARENTERAL ROUTES:

PRIMARY PARENTERAL ROUTES Routes Usual volume ( mL ) Needle commonly used Formulation constraints Types of medication administered SVP Sub cutaneous 0.5-2 5/8 in. , 23 gauge Need to be isotonic Insulin, vaccines Intra muscular 0.5-2 1.5 in. , 23 gauge Can be solutions, emulsions, oils or suspensions Isotonic preferably Nearly all drug classes Intra venous 1-1000 Vein puncture 1.5 in. , 20-22 gauge Solutions, emulsions and liposomes Nearly all drug classes LVP 101 and larger (infusion unit) Venoclysis 1.5 in. , 18-19 gauge Solutions and some emulsions Nearly all drug classes

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S. No. ADVANTAGES DISVANTAGES 1. Quick onset Wrong dose or over dose can be fatal 2. Vomiting and unconscious patients can take Pain at site 3. Prolonged action by modified formulation ( Depot) Trained person required 4. Nutritive fluids (glucose, electrolytes) can be given Expensive 5. Drugs with poor absorption or instability from GIT NECESSITY OF ASEPTIC CONDITIONS IN PRODUCTION, COMPOUNDING AND ADMINISTRATION

PARENTERAL FORMULATION:

PARENTERAL FORMULATION VEHICLES Aqueous vehicles Water for injection USP Water for injection free from CO 2 (Barbiturates & Sulfonamides) Sterile water for injection USP Bacteriostatic water for injection USP Sodium chloride injection USP Bacteriostatic Sodium chloride injection USP Ringers injection USP Lactated Ringers injection USP Non aqueous vehicles Fixed oils Ethyl alcohol, propylene glycol, PEG

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ADJUVANTS Solubilising agents Surfactants (polysorbate, tweens) Stabilizers Antioxidants (thiourea, ascorbic acid, sodium bisulphite, sodium metabisulphite) Buffering agents acetates, citrates and phosphates Anti bacterial agents Phenol or cresol, chlorocresol, phenyl mercuric nitrate, bezalkonium chloride

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Tonicity contributors Sodium chloride, Dextrose , Boric acid Chelating agents EDTA Suspending agents Methyl cellulose, CMC, gelatin , acacia Emulsifying agents Lecithin Wetting agent tween 80 , sorbitan trioleate

CONTAINERS AND CLOSURES :

CONTAINERS AND CLOSURES Glass Glass containers Type I are best for aqueous preparations(vials & ampoules). Siliconization inside surface is done to prevent interaction. Plastics polypropylene containers can withstand autoclaving. Rubber closures permit needle into multiple-dose vial. It is held by aluminum band. In addition a vulcanizing agent – sulfur an accelerator - 2- mercaptobenzothiazole an activator – zinc oxide filters – carbon black or lime stone antioxidant and lubricants [lacquer or plastic coating prevent their leaching.]

PROCESSING OF PARENTERALS:

PROCESSING OF PARENTERALS S.No . STEPS 1. Cleaning of containers, closures and equipments 2. Collection of materials 3. Preparation of parenteral products 4. Filtration 5. Filling the preparation in final containers 6. Sealing the containers 7. Sterilization 8. Evaluation of parenteral preparation 9. Labeling and packaging

Ampoules sealing:

Ampoules sealing

HEPA(HIGH EFFICIENCY PARTICULATE AIR) FILTER Remove at least 99.97% of airborne particles 0.3  µm in diameter :

HEPA(HIGH EFFICIENCY PARTICULATE AIR) FILTER Remove at least 99.97% of airborne particles 0.3  µm in diameter EFFICIENCY OF FILTER IS CHECKED BY DOP (DIOCTYL PTHALATE TEST) DOP vapor (particle size 0.3 μ m) is passed by HEPA filter and on opposite smoke detector is used to detect its vapor.

METHODS OF STERLIZATION:

METHODS OF STERLIZATION Steam sterilization – by denaturation of organism’s essential protein 10 pounds ( 115.5˚ C ) for 30 minutes 15 pounds ( 121.5˚ C ) for 20 minutes 10 pounds ( 126.5˚ C ) for 15 minutes

Convection hot air sterilizer:

Convection hot air sterilizer DRY HEAT STERLIZATION MILLER FILTER UNIT

Colourless mixed with co2 as it is flammable con must be 500 mL/L:

Colourless mixed with co2 as it is flammable con must be 500 mL /L ETHYLENE OXIDE GAS STERLIZATION IONIZING RADIATION GAS STERLIZATION

Microbial Death Kinetic:

Microbial Death Kinetic D value refers to the time or dose required to reduce the microbial population by one decimal point or for 90% reduction under a given set of conditions Resistance value (Z) : Z value can be defined as the increase in temperature required decreasing the D-value of an organism by 90% F value : Number of minutes required to kill a known population of microorganisms in a given product under specified conditions.

ENDOTOXIN TESTING:

ENDOTOXIN TESTING RABBIT TEST LAL TEST

RABBIT PYROGEN TEST:

RABBIT PYROGEN TEST Measure the change in température of 3 rabbits, after intravenous injection of the test solution.

Limulus amebocyte lysate (LAL) Test:

Limulus amebocyte lysate (LAL) Test Horseshoe Crabs Being Bled

LAL Test:

LAL Test Blood is removed from horseshoe crab's pericardium & separated from serum using centrifugation and are then placed in distilled water, which causes them to swell up & burst ("lyse"). This releases the chemicals from the inside of the cell (the "lysate"), which is then purified and freeze-dried. To test a sample for endotoxins, it is mixed with lysate and water; endotoxins are present if coagulation occurs.

FREEZE-DRYING:

FREEZE-DRYING Freeze-drying (also known as lyophilization or cryodesiccation ) is a dehydration process which works by freezing the material and then reducing the surrounding pressure and adding enough heat to allow the frozen water in the material to sublime It is important to cool the material below its triple point, the lowest temperature at which the solid and liquid phases of the material can coexist.

HVAC Systems Heating Ventilation Air Conditioning :

HVAC Systems H eating V entilation A ir C onditioning

A Qualification approach for HVAC Systems:

A Qualification approach for HVAC Systems

Measuring the Air Pressure Cascade :

Measuring the Air Pressure Cascade Pressure Cascade A process whereby air flows from the cleanest area, which is maintained at the highest pressure to a less clean area at a lower pressure. It is measured with a portable magnahelic gauge or micro manometer.

PowerPoint Presentation:

Airflow Volume Measurement Purpose To check the airflow volume to calculation of the air change rate Not required in clean rooms with unidirectional (laminar) airflow Requirements Cleanroom installation completed (Ceiling, filter, raised floor, walls, doors etc.) Air volume adjustment performances in the order of the maintenance group

TEST METHODS :

TEST METHODS Air Velocity Measurement Purpose To check the air velocity distribution Not required in cleanrooms with turbulent airflow (Recovery test) Requirements Cleanroom installation completed (Ceiling, filter, raised floor, walls, doors etc.) Velocity adjustment performances in the order of the maintenance group

STAFF DRESS CODE SUIT IS MADE OF DACRON, NYLON OR TERYLENE :

STAFF DRESS CODE SUIT IS MADE OF DACRON, NYLON OR TERYLENE

AIRBORNE VIABLE PARTICULATE COUNT - EQUIPMENT:

AIRBORNE VIABLE PARTICULATE COUNT - EQUIPMENT Passive air monitoring Petri dish with agar Active air monitoring Slit-to-Agar (STA) Sieve Impactors Centrifugal Impactors Filtration Liquid Impingement Gelatin Filter Sampler

LAYOUT OF STERILE PRODUCTS AREA:

LAYOUT OF STERILE PRODUCTS AREA

First the materials are passed through class 100,000 i.e. grade D environment for presterilization:

First the materials are passed through class 100,000 i.e. grade D environment for presterilization The preparation areas are supplied with HEPA filters. Transfer of materials are carried out in air-locks to avoid cross contamination The preparation place is Class 100 area

Production area:

Production area

PowerPoint Presentation:

INSULIN JET INJECTOR

TUBEX closed injection device:

TUBEX closed injection device

PowerPoint Presentation:

Email [email protected] FOR YOUR TIME

ANY QUESTIONS:

ANY QUESTIONS

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