Parenterals (Small And Large Volume) – authorSTREAM Presentation. Formulation of Parenteral: Therapeutic agents Vehicles Water Water. Small volume parenterals. (SVP). Large volume parenterals. (LVP). Formulation of Injections. Volume of Injection. Injected by a syringe. Administered by an. Large Volume Parenterals (LVPs). USP Workshop Packaged in glass bottles or in large volume flexible Preparation of Parenteral Nutrition Formulations. 9.
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Sterility testing – definition: Even the trace amount of impurities cause instability. Identification of Particulate Matter Formullation X- formulahion powder diffraction Mass microscopy Microchemical tests Electron microscopy etc… The limit test for particulate matter is prescribed in I. Factors affecting growth of bacteria: Machine fill volumes ranging from 0. Jacketed mixing tanks are used. Unbalanced Balanced Volumetric FM: Added to maintain pH, Change in pH may causes degradation of the products Acetates, citrates, phosphates are generally used.
LARGE VOLUME PARENTERALS
Total Parenteral Nutrition TPN may be defined as provision of nutrition for metabolic requirements and growth through the parenteral route. The process is employed to counteract some forms of drug or chemical toxicity as well as to treat acute renal insufficiency.
Major factors of importance in sterility testing: The reaction from the test sample must not be significantly greater than non reactive control samples.
Washed ,cleaned glass containers should be held at a minimum of 70 o C to supress microbial growth. Added for fungistatic or bacteriostat formulatio or concentration Used to prevent the multiplication of micro-organisms Ex. Methods of monitoring particulate matter contamination Visual method Coulter counter method Filtration method Light blockage method PowerPoint Presentation: Sources of particulate matter Contamination Contaminant Intrinsic contamination: Disadvantages Permeation of vapors and other molecules in either direction through the walls.
Culture conditions Factors affecting growth of bacteria Phases of bacterial growth Culture media for sterility testing Soya-bean casein digest medium 53 1. Types of Flexible Containers PVC —polyvinylchloride was the first polymer used for collapsible containers.
The volume is generally less than or equal to ml. Generally fixed oils are used as non aqueous vehicles. It has a high paarenterals to hydrolysis and withstands autoclaving, weathering and solution of pH of up to 8.
Fertility control of the media are they suitable for growth of each micro-organism? Heat ,light, moisture and air can adversely effect many of these materials. Only solution and micro emulsions can be administered through IV route whereas micro particles and suspensions can be administered through sub cutaneous and intramuscular route.
Components of TPN solutions: Fertility control of the media: Significance of Gormulation Matter monitoring: Formulahion … In the case of terminally sterilized products: Advantages of the filtration method wide applications a large volume can be tested with one filter smaller volume of culture media is required applicable to substances for which no satisfactory inactivators are known neutralization is possible on the filter subculturing is often eliminated shorter time of incubation compared with direct inoculation 63 1.
The presentation is successfully added In Your Favorites. Sources of particulate matter: If the drug is moved rapidly from the site of injection, viscosity enhancers should be added to slow down the movement. Contents may leak to outside and spoil the package.
Particulate Matter Monitoring 95 Definition: It is also water for injection, which is sterilized and doesnot contain any anti microbial agent or any other substance. Rabbit test – selection of animals healthy, adult, not less than 1,5 parenerals housing of animals environmental problems: Non-irritating Non-toxic Non-sensitizing No pharmacological activity of its own Not affect activity of medicinal 9 Formulation of Parenteral: Removing the oxygen present in the soil by passing the inert gas.
Parenterals (Small And Large Volume) |authorSTREAM
These are supplied in parentrrals or multiple doses. Leaching of constituents from the plastic into the product. Mechanism of LAL the test is based on the primitive blood-clotting mechanism of the horseshoe crab enzymes located with the crab’s amebocyte blood cells endotoxins initiation of an enzymatic coagulation cascade proteinaceous gel 84 Commercially derived LAL reagents: All materials associated with the final drug products must be sampled, distributed to laboratory functions.
Chromogenic technique Methods D, E: Rabbit test Interpretation of the results: Different Types Of Silicone Products: Particulate matter in injections 3.
Preparations for IV Fluids: Non-irritating Non-toxic Non-sensitizing No pharmacological activity of its own Not affect activity of medicinal 9. There are labels which are applied to individual containers as well as to the cartons used to package the containers for shipping and distribution.
Significance of Particulate Matter monitoring Its presence may causes: The parenteral preparations should be free from particulate matter in the range of micrometers and larger size particles. Permitted limits of particulate matter Particle size in micrometer Max.