logging in or signing up Small Volume Parenterals robin_vinnu Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 2790 Category: Education License: All Rights Reserved Like it (8) Dislike it (0) Added: October 31, 2010 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: ruimania (4 month(s) ago) dear friend, please allow to doaload this ppt, i really like it! Saving..... Post Reply Close Saving..... Edit Comment Close By: shivkumarsamrat (9 month(s) ago) please allow me to download this presentation ppt...these are very nice ppt.. Saving..... Post Reply Close Saving..... 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Parenteral products are injected through the skin or mucous membranes into the internal body compartments. These are the preparations which are given other than oral routes. Slide 3: 3 1657: First recorded injection in animals - Sir Christopher Wren 1855: First subcutaneous injections of drugs using hypodermic needles Dr. Alexander Wood 1920s: Proof of microbial growth resulting in infections - Dr. Florence Seibert 1926: inclusion in the National Formulary 1933: Application of freeze drying to clinical materials 1944: Discovery of ethylene oxide 1946: Organization of Parenteral drug Association. 1961: Development of laminar air flow concept 1965: Development of Total Parenteral nutrition(TPN) History of parenterals : CONTENTS : 4 CONTENTS Definition Introduction Advantages Disadvantages Routes of administration Formulation of product (SVP) Manufacture of SVP Packaging Sterilization Quality assurance Quality control Conclusion DEFINITION : 5 DEFINITION According to USP : “ an injection that is packaged in containers labeled as containing 100 ml or less” INTRODUCTION : 6 INTRODUCTION All the sterile products packaged in vials, ampoules, cartridges, syringes, bottles or any other container that is 100ml or less fall under the class of SVP. Ophthalmic products packaged in squeezable plastic containers, although topically applied to the eye rather than administered by injection, also fall under the classification of Small Volume Injections (SVI) as long as the container size is 100ml or less. SVP aqueous solutions can be administered by intravenous route because of local irritation. Small volume parenteral products can be formulated and packaged in several ways and include a wide variety of products like : Slide 7: 7 Pharmaceutical products. Biological products. Diagnostic agents. Allergenic extracts. Radiopharmaceutical products. Dental products. Genetically engineered or biotechnology products. Liposome and lipid products. ADVANTAGES : 8 ADVANTAGES Quick onset of action Suitable for the drugs which are not administered by oral route Useful for unconscious or vomiting patients. Useful for patients who cannot take drugs orally Useful for emergency situations Duration of action can be prolonged by modifying formulation. Can be done in hospitals, ambulatory infusion centers, and home health care DISADVANTAGES : 9 DISADVANTAGES Pain on injection. Difficult to reverse an administered drug’s effects. Sensitivity or allergic reaction at the site of injection. Requires strict control of sterility & non pyrogenicity than other formulation. Only trained person is required Require specialized equipment, devices, and techniques to prepare and administer drugs. More expensive and costly to produce. ROUTES OF ADMINISTRATION : 10 ROUTES OF ADMINISTRATION Three primary routes of parenteral administration are commonly employed : Subcutaneous Intramuscular Intravenous Other routes : Intra – arterial Intrathecal Intraepidural Intracisternal Intraarticular Intracardial Intrapleural Intradermal Formulation of SVP : 11 Formulation of SVP Aqueous vehicle : Water For Injection(WFI) USP : Highly purified water used as a vehicle for injectable preparations which will be subsequently sterilized. USP requirement include not more than 10 parts per million of total solids. pH of 5.0 to 7.0 WFI may prepared by either distillation or reverse osmosis. Stored for less than 24hr at RT or for longer times at specific temperatures. Should be meet USP pyrogen test It may not contain any added substances. Stored in chemically resistant tank. Slide 12: 12 Bacteriostatic Water for Injection (BWFI) : This type of water used for making parenteral solutions prepared under aseptic conditions and not terminally sterilized. Need to meet USP sterility test. It can contain an added bacteriostatic agent when in containers of 30ml or less Slide 13: Sterile Water for Injection USP SWFI containing one or more suitable bacteriostatic agents. Multiple-dose containers not exceeding 30 ml. They are permitted to contain higher levels of than WFI because of the possible leaching of glass container. Sterile Water for Irrigation. Wash wounds, surgical incisions, or body tissues. Types of Water described in USP : Types of Water described in USP Slide 15: Water-miscible vehicles : primarily to effect solubility of drugs and/or reduce hydrolysis Non-aqueous vehicles : Fixed oils (vegetable origin, liquid, and rancid resistance, unsaturated, free fatty acid content) – Peanut oil – Corn oil – Cotton seed oil (depo-testosterone) – Sesame oil – Soybean oil (source of fat in intralipid) – Ethyl oleate – Isopropyl myristate Slide 16: Additives in parenteral products : Antibacterial Agents Required to prevent microorganism growth Limited concentration of agents - Phenylmercuric nitrate and Thiomersol 0.01% - Benzethonium chloride and benzalkonium chloride 0.01% - Phenol or cresol 0.5% - Chlorobutanol 0.5% Buffers Added to maintain pH Results in stability Effective range, concentration, chemical effect – Citrate and Acetate buffer – Sodium benzoate and benzoic acid – Sodium titrate and tartaric acid – Phosphate buffer Slide 17: Tonicity Agents Chelating agents Reduce pain of injection – ethylenediamine tetraacetic acid Can include buffers - Sodium chloride - Potassium chloride Inert Gases - Dextrose N2 (gentamycin sulfate injection) - mannitol - sorbitol CO2 (sodium bicarbonate injection) Surfactants polyoxyethylene sorbitan monooleate sorbitan monooleate MANUFACTURING OF SVP : MANUFACTURING OF SVP packaging : packaging Glass containers : Slide 21: Plastic containers : Closures : Slide 22: Sealing Ampoules Ampoules are unique in that the primary and secondary seal are the same. Ampoules are sealed by melting a portion of glass in a flame. Pull seal – Slow, Reliable, powder or other types with wide opening Roll or Tip seal Slide 23: Sealing of Bottles, Cartridges and Vials Primary seal consisting of a tight rubber or plastic closure and secondary seal that holds the primary seal in place. Secondary seals are usually aluminum caps that are crimped on to a thread less container. STERILIZATION : STERILIZATION Steam sterilization Dry heat sterilization Sterilization by filtration Gas sterilization Sterilization by ionizing radiation Slide 25: PREFILLED SYRINGES : Administration is more convenient for healthcare professionals and end users. Reduction of medication errors, better dose accuracy. Better use of controlled drugs such as narcotics. easy storage and disposal. QUALITY ASSURANCE : QUALITY ASSURANCE It includes : - Material management - Equipment and facility management - Personnel management - Documentation control QUALITY CONTROL : QUALITY CONTROL STERILITY TESTING - Membrane filtration - Direct inoculation of culture media membrane filtration Slide 28: Direct inoculation of the culture medium Slide 29: Pyrogen test : Pyrogenic - means producing fever Pyrogens - fever inducing substances Endotoxins Produced mostly by gram-negative bacteria Endotoxin - complex of pyrogenic lipopolysaccharide, a protein and inert lipid. Slide 30: LAL test : Limulus polyphemus = horseshoe crab Limulus - genera of crab Amebocyte - crab blood cell from which active component is derived Lysate - component is obtained by separating amebocytes from the plasma and then lysing them. The hearts of mature crabs are punctured and bled to collect the circulating amebocyte blood cells. Slide 31: Since amebocytes act as activators of the coagulation mechanism in the crab, an antiaggregating agent must be added to inhibit aggregation. N-Ethylmaleimade is the most commonly used anti- aggregant. LAL test is the combinationof 0.1 ml test sample with 0.1 ml LAL reagent. After 1 hour incubation at 37°C, the mixture is analyzed for the presence of a gel clot. The LAL test is positive, indicating the presence of endotoxin, if the gel clot maintains its integrity after slow inversion of the test tube containing the mixture. Advantages of LAL : Advantages of LAL Greater Sensitivity Less Variability Much Less False Positives Much Less Expensive Alternative to Animal Model cheaper, more accurate than other is performed in the pharmaceutical laboratory specific for endotoxins of gram-negative origin particularly useful for: Radiopharmaceuticals and cytotoxic agents Products with marked pharmacological or toxicological activity in the rabbit (e.g. insulin) Blood products which sometime give misleading results in the rabbit Water for injection where LAL test is potentially more stringent and readily applied Slide 33: Particulate Matter : Unwanted mobile insoluble matter other than gas bubbles present in the given product. It may be dangerous when the particle size is larger than R.B.C. & may block the blood vessel. Visual method Coulter counter method Filtration method Light blockage method Slide 34: LEAKER TEST : Immersing the ampoules in a dye solution 1% metylene blue 25 in (64cm) of vacuum for a minimum of 15 min. The vacuum on the tank is then released as rapidly as possible to put maximum stress on weak seals. Defective ampoules will contain blue solution. conclusion : conclusion A wide variety of devices and new methods of drug delivery employed. Each has its advantage and disadvantages, which have to be carefully considered by the therapist. One must understand and appreciate that since parenteral medications and frequently, body fluids or come into contact with most parenteral drug delivery devices. They must be free of contaminating microorganism, harmful substances, free of pyrogenic contamination, free of particulate matter. In coming future we can expect much more advance technology in utilizing parenteral products for safety desirable effects in human being. Slide 36: REFERENCES : Pharmaceutical Dosage Forms. Lieberman, Herbert A. Vol. 1: Parenteral Medications. Pharmaceutical Dosage Forms. Avis, Kenneth E. Vol. 2: Parenteral Medications Pharmaceutical Dosage Forms. Avis, Kenneth E Vol. 3 : Parenteral Medications Parenteral Quality Control. Michael J. Akers and Daniel S. Larrimore (Marcel Dekker, second edition.1993). Modern Pharmaceutics. Gilbert S. Banker, Christopher T. Rhodes. Fourth Edition. www.google.com www.pharmaceuticalonline.com Slide 37: Thank you You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Small Volume Parenterals robin_vinnu Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 2790 Category: Education License: All Rights Reserved Like it (8) Dislike it (0) Added: October 31, 2010 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: ruimania (4 month(s) ago) dear friend, please allow to doaload this ppt, i really like it! Saving..... Post Reply Close Saving..... Edit Comment Close By: shivkumarsamrat (9 month(s) ago) please allow me to download this presentation ppt...these are very nice ppt.. Saving..... Post Reply Close Saving..... Edit Comment Close By: rohith6699 (9 month(s) ago) plz give permission for download Saving..... Post Reply Close Saving..... Edit Comment Close By: rohith6699 (9 month(s) ago) nbgkjbkg Saving..... Post Reply Close Saving..... Edit Comment Close By: haribabuj (10 month(s) ago) it good presentation Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Seminar On : 1 Seminar On Small Volume Parenterals Presented by M. Venkata Ramana Reddy M. Pharmacy I Semester Pharmaceutics St. Peter’s Institute of Pharmaceutical Sciences Hanamkonda, Warangal Slide 2: 2 A BRIEF ABOUT PARENTERALS : para: outside enteron: intestine (i.e. beside the intestine) Any drug or fluid whose delivery does not utilize the alimentary canal for entry into body tissues. Drugs applied topically to the eye, ear & skin or even inhaled may be broadly interpreted as parenterals. Parenteral products are injected through the skin or mucous membranes into the internal body compartments. These are the preparations which are given other than oral routes. Slide 3: 3 1657: First recorded injection in animals - Sir Christopher Wren 1855: First subcutaneous injections of drugs using hypodermic needles Dr. Alexander Wood 1920s: Proof of microbial growth resulting in infections - Dr. Florence Seibert 1926: inclusion in the National Formulary 1933: Application of freeze drying to clinical materials 1944: Discovery of ethylene oxide 1946: Organization of Parenteral drug Association. 1961: Development of laminar air flow concept 1965: Development of Total Parenteral nutrition(TPN) History of parenterals : CONTENTS : 4 CONTENTS Definition Introduction Advantages Disadvantages Routes of administration Formulation of product (SVP) Manufacture of SVP Packaging Sterilization Quality assurance Quality control Conclusion DEFINITION : 5 DEFINITION According to USP : “ an injection that is packaged in containers labeled as containing 100 ml or less” INTRODUCTION : 6 INTRODUCTION All the sterile products packaged in vials, ampoules, cartridges, syringes, bottles or any other container that is 100ml or less fall under the class of SVP. Ophthalmic products packaged in squeezable plastic containers, although topically applied to the eye rather than administered by injection, also fall under the classification of Small Volume Injections (SVI) as long as the container size is 100ml or less. SVP aqueous solutions can be administered by intravenous route because of local irritation. Small volume parenteral products can be formulated and packaged in several ways and include a wide variety of products like : Slide 7: 7 Pharmaceutical products. Biological products. Diagnostic agents. Allergenic extracts. Radiopharmaceutical products. Dental products. Genetically engineered or biotechnology products. Liposome and lipid products. ADVANTAGES : 8 ADVANTAGES Quick onset of action Suitable for the drugs which are not administered by oral route Useful for unconscious or vomiting patients. Useful for patients who cannot take drugs orally Useful for emergency situations Duration of action can be prolonged by modifying formulation. Can be done in hospitals, ambulatory infusion centers, and home health care DISADVANTAGES : 9 DISADVANTAGES Pain on injection. Difficult to reverse an administered drug’s effects. Sensitivity or allergic reaction at the site of injection. Requires strict control of sterility & non pyrogenicity than other formulation. Only trained person is required Require specialized equipment, devices, and techniques to prepare and administer drugs. More expensive and costly to produce. ROUTES OF ADMINISTRATION : 10 ROUTES OF ADMINISTRATION Three primary routes of parenteral administration are commonly employed : Subcutaneous Intramuscular Intravenous Other routes : Intra – arterial Intrathecal Intraepidural Intracisternal Intraarticular Intracardial Intrapleural Intradermal Formulation of SVP : 11 Formulation of SVP Aqueous vehicle : Water For Injection(WFI) USP : Highly purified water used as a vehicle for injectable preparations which will be subsequently sterilized. USP requirement include not more than 10 parts per million of total solids. pH of 5.0 to 7.0 WFI may prepared by either distillation or reverse osmosis. Stored for less than 24hr at RT or for longer times at specific temperatures. Should be meet USP pyrogen test It may not contain any added substances. Stored in chemically resistant tank. Slide 12: 12 Bacteriostatic Water for Injection (BWFI) : This type of water used for making parenteral solutions prepared under aseptic conditions and not terminally sterilized. Need to meet USP sterility test. It can contain an added bacteriostatic agent when in containers of 30ml or less Slide 13: Sterile Water for Injection USP SWFI containing one or more suitable bacteriostatic agents. Multiple-dose containers not exceeding 30 ml. They are permitted to contain higher levels of than WFI because of the possible leaching of glass container. Sterile Water for Irrigation. Wash wounds, surgical incisions, or body tissues. Types of Water described in USP : Types of Water described in USP Slide 15: Water-miscible vehicles : primarily to effect solubility of drugs and/or reduce hydrolysis Non-aqueous vehicles : Fixed oils (vegetable origin, liquid, and rancid resistance, unsaturated, free fatty acid content) – Peanut oil – Corn oil – Cotton seed oil (depo-testosterone) – Sesame oil – Soybean oil (source of fat in intralipid) – Ethyl oleate – Isopropyl myristate Slide 16: Additives in parenteral products : Antibacterial Agents Required to prevent microorganism growth Limited concentration of agents - Phenylmercuric nitrate and Thiomersol 0.01% - Benzethonium chloride and benzalkonium chloride 0.01% - Phenol or cresol 0.5% - Chlorobutanol 0.5% Buffers Added to maintain pH Results in stability Effective range, concentration, chemical effect – Citrate and Acetate buffer – Sodium benzoate and benzoic acid – Sodium titrate and tartaric acid – Phosphate buffer Slide 17: Tonicity Agents Chelating agents Reduce pain of injection – ethylenediamine tetraacetic acid Can include buffers - Sodium chloride - Potassium chloride Inert Gases - Dextrose N2 (gentamycin sulfate injection) - mannitol - sorbitol CO2 (sodium bicarbonate injection) Surfactants polyoxyethylene sorbitan monooleate sorbitan monooleate MANUFACTURING OF SVP : MANUFACTURING OF SVP packaging : packaging Glass containers : Slide 21: Plastic containers : Closures : Slide 22: Sealing Ampoules Ampoules are unique in that the primary and secondary seal are the same. Ampoules are sealed by melting a portion of glass in a flame. Pull seal – Slow, Reliable, powder or other types with wide opening Roll or Tip seal Slide 23: Sealing of Bottles, Cartridges and Vials Primary seal consisting of a tight rubber or plastic closure and secondary seal that holds the primary seal in place. Secondary seals are usually aluminum caps that are crimped on to a thread less container. STERILIZATION : STERILIZATION Steam sterilization Dry heat sterilization Sterilization by filtration Gas sterilization Sterilization by ionizing radiation Slide 25: PREFILLED SYRINGES : Administration is more convenient for healthcare professionals and end users. Reduction of medication errors, better dose accuracy. Better use of controlled drugs such as narcotics. easy storage and disposal. QUALITY ASSURANCE : QUALITY ASSURANCE It includes : - Material management - Equipment and facility management - Personnel management - Documentation control QUALITY CONTROL : QUALITY CONTROL STERILITY TESTING - Membrane filtration - Direct inoculation of culture media membrane filtration Slide 28: Direct inoculation of the culture medium Slide 29: Pyrogen test : Pyrogenic - means producing fever Pyrogens - fever inducing substances Endotoxins Produced mostly by gram-negative bacteria Endotoxin - complex of pyrogenic lipopolysaccharide, a protein and inert lipid. Slide 30: LAL test : Limulus polyphemus = horseshoe crab Limulus - genera of crab Amebocyte - crab blood cell from which active component is derived Lysate - component is obtained by separating amebocytes from the plasma and then lysing them. The hearts of mature crabs are punctured and bled to collect the circulating amebocyte blood cells. Slide 31: Since amebocytes act as activators of the coagulation mechanism in the crab, an antiaggregating agent must be added to inhibit aggregation. N-Ethylmaleimade is the most commonly used anti- aggregant. LAL test is the combinationof 0.1 ml test sample with 0.1 ml LAL reagent. After 1 hour incubation at 37°C, the mixture is analyzed for the presence of a gel clot. The LAL test is positive, indicating the presence of endotoxin, if the gel clot maintains its integrity after slow inversion of the test tube containing the mixture. Advantages of LAL : Advantages of LAL Greater Sensitivity Less Variability Much Less False Positives Much Less Expensive Alternative to Animal Model cheaper, more accurate than other is performed in the pharmaceutical laboratory specific for endotoxins of gram-negative origin particularly useful for: Radiopharmaceuticals and cytotoxic agents Products with marked pharmacological or toxicological activity in the rabbit (e.g. insulin) Blood products which sometime give misleading results in the rabbit Water for injection where LAL test is potentially more stringent and readily applied Slide 33: Particulate Matter : Unwanted mobile insoluble matter other than gas bubbles present in the given product. It may be dangerous when the particle size is larger than R.B.C. & may block the blood vessel. Visual method Coulter counter method Filtration method Light blockage method Slide 34: LEAKER TEST : Immersing the ampoules in a dye solution 1% metylene blue 25 in (64cm) of vacuum for a minimum of 15 min. The vacuum on the tank is then released as rapidly as possible to put maximum stress on weak seals. Defective ampoules will contain blue solution. conclusion : conclusion A wide variety of devices and new methods of drug delivery employed. Each has its advantage and disadvantages, which have to be carefully considered by the therapist. One must understand and appreciate that since parenteral medications and frequently, body fluids or come into contact with most parenteral drug delivery devices. They must be free of contaminating microorganism, harmful substances, free of pyrogenic contamination, free of particulate matter. In coming future we can expect much more advance technology in utilizing parenteral products for safety desirable effects in human being. Slide 36: REFERENCES : Pharmaceutical Dosage Forms. Lieberman, Herbert A. Vol. 1: Parenteral Medications. Pharmaceutical Dosage Forms. Avis, Kenneth E. Vol. 2: Parenteral Medications Pharmaceutical Dosage Forms. Avis, Kenneth E Vol. 3 : Parenteral Medications Parenteral Quality Control. Michael J. Akers and Daniel S. Larrimore (Marcel Dekker, second edition.1993). Modern Pharmaceutics. Gilbert S. Banker, Christopher T. Rhodes. Fourth Edition. www.google.com www.pharmaceuticalonline.com Slide 37: Thank you