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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WordPress Embed Customize Embed. Presentation Description No description available. This is very useful presentation for Quick Understanding. Kindly Send it this presentation on vishald gmail. These are Sterile, Pyrogen free preparations intended to be administered parenterally outside alimentary tract.

Quick onset of action Suitable for the drugs which are not administered by oral route Useful for unconscious tormulation vomiting patients. Duration of action can be prolonged by modifying formulation. General steps involved 1. Preparation of bulk products 3. Filling of solution in or product in ampoule or vial 7. Tests for Quality control 5. Sterilization 6 Formulation of Parenteral: Formulation of Parenteral 1.

Formulation of Parenteral Solvents Solvents used must be: Non-irritating Non-toxic Non-sensitizing No pharmacological activity of its own Not affect activity of medicinal 9 Formulation of Parenteral: Added substances Additives Antimicrobials: Added for fungistatic paernterals bacteriostat action or concentration Used to prevent the multiplication of micro-organisms Ex.

Benzyl alcohol 0. Multidose containers must have preservatives unless prohibited by monograph. Large volume parenteral must not contain preservative becoz it may be dangerous to human body if it contain in high doses. Used to protect product from oxidation Acts as reducing agent or prevents oxidation Ex: Ascorbic acid — 0. Ascorbic acid esters- 0. Ascorbic acidCitric acidTartaric acid D Chelating agent: Added to maintain pH, Change in pH may causes degradation of the products Acetates, citrates, phosphates are generally used.

Factors affecting selection of buffers: Acetic acid ,adipic acid, benzoic acid, citric acid, lactic acid Used in the conc. Used to form the complex with the metallic ions present in the formulation so that the ions will not interfere during mfg. They form a complex which gets dissolved in the solvents. Disodium edetate — 0. As parenterals are available in solution praenterals they are most prone to unstabilize Used to stabilize the formulation Maintain stable Examples: Used to increase solubility of slightly soluble drugs they acts by any one of the following: Used to reduce the parsnterals of injection.

Buffers may acts as tonicity contributor as well as stabilizers for the pH. Isotonicity depends on permeability of a living semipermaeable membrane Hypotonic: Must check each individual monogram for: The batch is send to packing after issuing satisfactory reports of analysis from QC If any problem is observed in above analysis the decision is to be taken for reprocessing or others.

Finishing and packaging area: The labeled container should be packed in cardboard or plastic containers Ampoules should be packed in partitioned boxes. Preparations for IV Fluids: Body fluids, Electrolyte replenisher Volume supplied: Sodium chloride injection IP: As a diuretic 33 PowerPoint Presentation: 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. Forrmulation of TPN solutions: The fluids used in dialysis are known as dialysis fluids.


Sterility testing – definition: Sterility testing – definition Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample foemulation of containers taken from batch of vvolume. Based on results obtained from testing the sample a decision is made as to the sterility of the batch.

Sterility testing – is made after the product exposition to the one of the possible sterilization procedures can only provide partial answers to the state of sterility of the product batch under test is inadequate as an assurance of sterility for a terminally sterilized product 41 Major factors of importance in sterility testing: Major factors of importance in sterility testing Parentrals environment in which the test is conducted The quality of the culture conditions provided The test method The sample size The sampling procedure 42 1.

Environmental conditions avoid accidental contamination of the product during the test the test is carried out under aseptic conditions regular microbiological monitoring should be carried out 43 1.

Culture conditions Appropriate conditions for the growth of any surviving organism should be provided by the culture media selection. Culture conditions Factors affecting growth of bacteria Phases of bacterial growth Culture media for sterility testing 45 1.

Factors affecting growth of bacteria: Phases of bacterial growth: Culture media for sterility testing: Culture media for sterility testing capable of initiating and maintaining the vigorous growth of a small number of organisms sterile Types of media: Fluid thioglycollate medium Soya-bean casein digest medium other media 49 1.

Fluid thioglycollate medium composition described in next slide. Fluid thioglycollate medium 51 1. Soya-bean casein digest medium: Soya-bean casein digest medium primarily intended for the culture of both fungi and aerobic bacteria parenetrals role of some ingredients incubation of the media: Soya-bean casein digest medium 53 1.

Fertility control of the media: Fertility control of the media are they suitable for growth of each micro-organism?

Effectiveness of the media under test conditions: Effectiveness of the media under test conditions are culture conditions satisfactory in the presence of the product being examined?

The test method for sterility of the product: The test method for sterility of the product Membrane filtration Direct inoculation of the culture medium 56 1. Membrane filtration Appropriate for: Selection of filters lf membrane filtration: Selection of filters for membrane filtration pore size of formulatiin. The procedure of membrane filtration: The procedure of membrane filtration sterilization of filtration system and membrane filtration of examined solution under aseptic conditions suitable volume, dissolution of solid particles with suitable solvents, dilution if necessary… one of two possible following procedures: Direct inoculation of the culture medium: Scheme for sterility test by membrane filtration Scheme for sterility test by direct inoculation 62 Advantages of the filtration method: 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.



Observation and interpretation of the results: Observation and interpretation of the results Examination at time intervals during the incubation period and at its conclusion When the sample passes the test and when fails?

When the test may be considered as invalid? There is low incidence of accidental contamination or false positive results 64 1.

Sampling Selection of the samples Sample size 65 Minimum number of items to be tested: Minimum number of items to be tested 66 Instead of the conclusion – Guidelines for using the test for sterility: Instead of the conclusion – Guidelines for using the test for sterility Precautions against microbial contamination The level of assurance provided by a satisfactory result of a test for sterility as applied to the quality of the batch is a function of: The homogeneity of the batch The conditions of manufacture Efficiency of the adopted sampling plan 67 Guidelines …: Guidelines … In the case of terminally sterilized products: Pyrogens Pyrogenic – means producing fever Pyrogens – fever inducing substances Having nature Endogenous inside body Exogenous outside body Exogenous pyrogens — mainly lipopolysaccharides bacterial origin, but not necessary 70 Structure of endotoxins: Structure of endotoxins Produced mostly by gram-negative bacteria Endotoxin – complex of pyrogenic lipopolysaccharidea protein and inert lipid; lipid part of the lipopolysaccharide is the main pyrogenic agent; polysaccharide part increases solubility 71 Sources of pyrogen contamination: Sources of pyrogen contamination solvent – possibly the most important source the medicament the apparatus the method of storage between preparation and sterilization 72 The endotoxin characteristics: The endotoxin characteristics thermostable water-soluble unaffected by the common bactericides non-volatile These are the reasons why pyrogens are difficult to destroy once produced in a product 73 Tests for pyrogenic activity: Reproducible pyrogenic response Other species not predictable Rabbit vs.

Rabbit test – selection of animals healthy, adult, not less than 1,5 kg,… housing of animals environmental problems: Rabbit test Preliminary test Sham Test intravenous injection of sterile pyrogen-free saline solution to exclude any animal showing an unusual response to the trauma shock of injection any animal showing a temperature variation greater than 0. Rabbit test – main test: Rabbit test Interpretation of the results: The result of pyrogen test: