PREPARATION OF INJECTIONS

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AImST UNIVERSITY

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Administration Dosage Form Formulation Stability Packaging and Labelling CONTENTS

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Para: outside enteron: intestine (i.e. beside the intestine) These are the preparations which are given other than oral routes. Injections: These are Sterile, Pyrogen free preparations intended to be administered parenterally (outside alimentary tract). PARENTERALS

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Rapid action Oral route can not be used Not effective except as injection biotechnology product (degradation in GIT tract) New drugs require to maintain potency & specificity so that they are given by parenteral . KEY POINTS

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Quick onset of action Suitable for the drugs which are not administered by oral route Useful for unconscious or vomiting patients. Duration of action can be prolonged by modifying formulation. Suitable for nutritive like glucose & electrolyte. Suitable for the drugs which are inactivated in GIT or HCl (GI fluid) Advantages:

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Once injected cannot be withdrawal. Injections may cause pain Self medication not possible If given by wrong route, difficult to control adverse effect Difficult to save patient if overdose Sensitivity or allergic reaction Requires strict control of sterility & non pyrogenicity than other formulation. Disadvantages

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Requirements of Parenteral preparations Sterility Pyrogen free Free particulate matter Clarity Stability Isotonicity

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Purity of solvent or vehicles Restrictions on buffers,stabilizers,peservative, coloring agents under aseptic conditions High quality packaging

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Subcutaneous (SC) Intramuscular (IM) Intravenous (IV) Intra-arterial (IA) Intrathecal Intraarticular Intrapleural Intracardial Intradermal Parental Routes of Administration

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Routes of parenteral medication

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The injection is given under the skin Need to be isotonic Upto 2 ml is given Using ½ to 1 inch 23 gauge needle or smaller needle Ex.Vaccines Insulin Scopolamine Epinephrine Subcutaneous (SC)

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Striated muscle fibre 0.5 to 2 ml sometimes upto 4 ml 1 to 1.5 inch & 19 to 22 gauge needle is used Preferably isotonic Principle sites: Gluteal (buttocks) Deltoid (upper arms) Vastus lateralis (lateral thigh) Ex.Solutions Emulsions Oils Suspension Intramuscular (IM)

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Into the vein 1 to 1000 ml 1 inch ,19 to 20 gauge needle with injection rate 1ml/ 10 sec. for volume upto 5 ml & 1 ml/ 20 sec. for volume more than 5 ml. Ex. Aqueous solutions Hydro alcoholic solutions Emulsions Liposome Intravenous (IV)

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IV infusion of large volume fluids (100- 1000 ml) has become increasingly popular. This technique is called as Venoclysis . This is used to supply electrolytes & nutrients to restore blood volume & to prevent tissue dehydration. Combination of parenteral dosage forms for administration as a unit product is known as an IV admixture. Lactated Ringer Injection USP NaCl Injection USP (0.9 %)– (replenish fluid & electrolyte) Dextrose Injection USP (fluid & electrolyte)

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Direct into the artery 2 to 20 ml 20 to 22 gauge Solutions & emulsions can be administered Ex. Radio opaque media Antineoplastic Antibiotics Intra-arterial (IA) Also called as diagnostic testing 0.05 ml ½ inch, 25 to 26 gauge needle Should be isotonic Ex.Diagnostic agents Intradermal

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Also called intra-spinal Directly given into the spinal cord 1 to 4 ml 24 to 28 gauge Must be isotonic Ex. LA Analgesics Neuroleptics Intrathecal

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Given directly into the joints 2 to 20 ml 5 inch 22 gauge Must be isotonic Ex. Morphine LA Steroids NSAID’s Antibiotics Intraarticular

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Given directly into the pleural cavity or lung Used for fluid withdrawal 2 to 30 ml 2 to 5 inch, 16 to 22 gauge needle Ex. LA Narcotics Chemotherapeutic agents Intrapleural

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Directly given into the heart 0.2 to 1 ml 5 inch , 22 gauge needle Ex.Cadiotonics Calcium salts as a calcium channel blockers Intracardial

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Solutions of Medicinal Example: Codeine Phosphate Injection Insulin Injection Dry solids or liquid concentrate does not contain diluents etc. Example: Sterile Ampicillin Sodium If diluents present, referred to as.....for injection Example: Methicillin Sodium for injection Suspensions "Sterile....Suspension" Example: Sterile Dexamethasone Acetate Suspension Dry solids, which upon the addition of suitable vehicles yield preparations containing in all respects to the requirements for sterile suspensions. Example: Sterile Ampicillin for Suspension Injectable Emulsions: Example: Propofol injection Types of Injections

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Formulation of Parenteral Therapeutic agents Vehicles Water miscible vehicles Non- aqueous vehicles Added substances (Additives) Antimicrobials Antioxidants Buffers Bulking agents Chelating agents Protectants Solubilizing agents Surfactants Tonicity- adjusting agents.

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Cleaning Preparation of bulk products Filtration Filling of solution in or product in ampoule or vial ests for Quality control Sealing Sterilization General steps involved

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1.Therapeutic ingredients Insulin Antibiotics Anticancer Steroids Vaccines Antipyretic Analgesics Anti- inflammatory LVP’s like Dextrose, NaCl or combination etc…. Water Should meet compendial requirements Water miscible vehicles Ethyl alcohol PEG PG Non aqueous vehicles Fixed oils Formulation of Parenteral . 2.Solvents: Solvent Non-irritating Non-toxic Non-sensitizing No pharmacological activity of its own Not affect activity of medicinal

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Added for fungistatic or bacteriostat action or concentration Used to prevent the multiplication of micro-organisms Ex.. Benzyl alcohol ------ 0.5 – 10 % Benzethonium chloride -- 0.01 % Methyl paraben ---- 0.01 – 0.18 % Propyl paraben --- 0.005 – 0.035 % Phenol --- 0.065 – 0.5 % Formulation of Parenteral . 3. Added substances (Additives) Antimicrobials 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. Preservatives

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Added to maintain pH, Change in pH may causes degradation of the products Acetates, citrates, phosphates are generally used. Factors affecting selection of buffers: Effective range, Concentration Chemical effect on the total product Ex. Acetic acid , adipic acid, benzoic acid, citric acid, lactic acid Used in the conc. of 0.1 to 5.0 % Buffers Used to form the complex with the metallic ions present in the formulation so that the ions will not interfere during mfg. of formulation. They form a complex which gets dissolved in the solvents. Examples: Disodium edetate – 0.00368 - .05 % Disodium calcium edetate - 0.04 % Tetrasodium edetate – 0.01 % Chelating agents

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As parenterals are available in solution form they are most prone to unstabilize Used to stabilize the formulation Maintain stable Examples: Creatinine – 0.5- 0.8 % Glycerin – 1.5 – 2.25 % Niacinamide – 1.25 -2.5 % Sodium saccharin – 0.03 % Sodium caprylate – 0.4 % Stabilizers Used to increase solubility of slightly soluble drugs they acts by any one of the following: solubilizers , emulsifiers or wetting agents. Examples: Dimethylacetamide , Ethyl alcohol Glycerin Lecithin PEG – 40 castor oil PEG – 300 Polysorbate 20, 40, 80 Solubilizing agents

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Used to reduce the pain 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 : swelling of cells (enlargement) Hypertonic: shrinking of cells (reduction) Example: Glycerin Lactose Mannitol Dextrose Sodium chloride Sorbitol Tonicity- adjusting agents

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Production facilities Stock room Compounding Area Clean Up Area Aseptic Area Quarantine Area Sterilization Storage Transport Packing and Labelling

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Lay Out Of Parenteral Manufacturing Area

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Non aseptic area Free from dust ,fibers & micro-organisms Constructed in such a way that should withstand moisture, steam & detergent Ceiling & walls are coated with material to prevent accumulation of dust & micro-organisms Exhaust fans are fitted to remove heat & humidity The area should be kept clean so that to avoid contamination to aseptic area The containers & closures are washed & dried in this area. Clean- up area

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The ingredients are mixed & preparation is prepared for filling Not essential that the area is aseptic Strict precaution is taken to prevent contamination from outside Cabinets & counters: SS Ceiling & walls : sealed & painted Preparation area

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Filtration & filling into final containers & sealing is done The entry of outside person is strictly prohibited To maintain sterility, special trained persons are only allowed to enter & work Person who worked should wear sterile cloths Should be subjected for physical examination to ensure the fitness Minimum movement should be there in this area Ceiling & walls & floors : sealed & painted or treated with aseptic solution and there should not be any toxic effect of this treatment Aseptic area

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SS Mechanical equipments : SS AIR: Free from fibres , dust & micro organisms HEPA filters are used which removes particles upto 0.3 micron Fitted in laminar air flow system, in which air is free from dust & micro organisms flows with uniform velocity Air supplied is under positive pressure which prevents particulate contamination from sweeping UV lamps are fitted to maintain sterility Cabinets & counters

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After filling, sealing & sterilization the products or batch is kept in this area The random samples are chosen and given for analysis to QC dept. The batch is send to packing after issuing satisfactory reports of analysis from QC If any problem is observed in above analysis the decision Quarantine area

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After proper label, the product is given for packing .Packing is done to protect the product from external environment The ideal Packing is that which protects the product during transportation, storage, shipping & handling. The labeled container should be packed in cardboard or plastic containers Ampoules should be packed in partitioned boxes. Finishing and packaging area

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EVALUTION PARENTERAL PRODUCTS Sterility testing - definition Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample number of containers taken from batch of product. 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

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Major factors of importance in sterility testing The environment in which the test is conducted The quality of the culture conditions provided The test method The sample size The sampling procedure Major factors of importance in sterility testing 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 1.Environmental conditions

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Culture conditions Appropriate conditions for the growth of any surviving organism should be provided by the culture media selection. 2.Culture conditions Culture conditions Factors affecting growth of bacteria Phases of bacterial growth Culture media for sterility testing 3.Culture conditions Factors affecting growth of bacteria : Factors affecting growth of bacteria Nutrition Moisture Air Temperature pH Light Osmotic pressure Growth inhibitors Phases of bacterial growth : Phases of bacterial growth Lag phase (A) Log (logarithmic or exponential) phase (B) Stationary phase (C) Decline (death) phase (D)

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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 Fluid thioglycollate medium : Fluid thioglycollate medium composition described in next slide. specific role of some ingredients primarily intended for the culture of anaerobic bacteria incubation of the media: 14 days at 30 -35°C Soya-bean casein digest medium : Soya-bean casein digest medium primarily intended for the culture of both fungi and aerobic bacteria specific role of some ingredients incubation of the media: 14 days at 20 -25°C

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Fertility control of the media : Fertility control of the media are they suitable for growth of each micro-organism? & apos ; Growth promotion test for aerobes, anaerobes and fungi & apos ; inoculation of media tubes with a MO incubation (T, t) the media are suitable if a clearly visible growth of the micro-organisms occurs 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? comparing the rate of onset and the density of growth of inoculated MO in the presence and absence of the material being examined growth control;

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Membrane filtration : The test method for sterility of the product Aqueous preparations alcoholic preparations oily preparations miscible with or soluble in aqueous or oily (solvents with no antimicrobial effect) solutions to be examined must be introduced and filtered under aseptic conditions All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood Selection of filters for membrane filtration : Selection of filters for membrane filtration pore size of 0.45 M  effectiveness established in the retention of micro-organisms appropriate composition the size of filter discs is about 50 mm in diameter

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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: the membrane is removed, aseptically transferred to container of appropriate culture medium passing the culture media through closed system to the membrane, incubation in situ in the filtration apparatus ( sartorius , millipore ).

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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 sub culturing is often eliminated shorter time of incubation compared with direct inoculation

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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 . In the case of terminally sterilized products: physical proofs, biologically based and automatically documented, showing correct treatment through the batch during sterilization are of greater assurance than the sterility test Products prepared under aseptic conditions: sterility test is the only available analytical method only analytical method available to the authorities who have to examine a specimen of a product for sterility.

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PYROGENS AND PYROGEN TESTING 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 PYROGENS Structure of endotoxins : Structure of endotoxins Produced mostly by gram-negative bacteria Endotoxin - complex of pyrogenic lipopolysaccharide , a protein and inert lipid; lipid part of the lipopolysaccharide is the main pyrogenic agent; polysaccharide part increases solubility

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Generalized structure of endotoxins Generalized structure of Endotoxins Generalized structure of endotoxins : 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 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

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