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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With the development in the field of bio-technology there is a development in the number of drugs administered parenterally. Based on the volume they are classified as: These are supplied in single or multiple doses. The volume is generally less than or equal to ml.
LARGE VOLUME PARENTERALS
These are supplied for single dosE having more than ml. These are delivered through IV route. These generally provide electrolytes, nutrition to the body. The drug is present in the form of powder and solvent is added to form solution that have the properties of injection.
As the lage suggests, the drug particles are suspended formullation suitable vehicle. Parenterals will be dispensed in several forms including solutions, suspensions, emulsions, nanosystems and powders which are made in to injection by addition of solvent. No material is added and water is treated by distillation or pareenterals osmosis. It has no smell and color.
Addition of 1 volumd 2 antimicrobial agents to water for injection results in bacteriostatic water for injection. Make sure that the anti microbial agent is compatible with the API which will be added in future. Is is simply water for injection which is sterilized without having antimicrobial agent.
It is also water for injection, which is sterilized and doesnot contain any anti microbial agent or any other substance. As the parenteral preparations are dilute vehicle occupies the larger part in parenteral preparation. As name suggest, this occupies some part of the vehicle and it helps in decreasing hydrolysis and to solubulise some drugs.
Ethyl alcohol, Propylene glycol. Generally fixed oils are used as non aqueous vehicles. According to USP vegetable oils should be used as they can metabolise and they will remain in liquid state at room conditions. Corn oil, Peanut oil, Cotton seed oil. These are used for harmone and vitamin preparations.
Chemically the drug molecule should be pure and the microbes, endotoxins should be within the limits. Even the trace lzrge of impurities cause instability. These include the substances that safeguard the purity of the formulation.
LARGE VOLUME PARENTRAL |authorSTREAM
They enhance the solubility of the drugs. Cyclo dextrins, Tween twenty and Tween eighty are complexing agents and Surfactants respectively. Tonicity adjusters make the preparation isotonic to body fluids to prevent irritation. They are used to prevent the interaction between proteins and glassware. Preservatives prevent the growth of micro organisms. Care must be taken while selecting the added substance as they can induce reaction that may inactivate API.
Some substances like proteins degrade with the change in PH. So these are used for chemical stability of product. Capacity of buffer should be low. These are some instances where buffers induce degradation of API. These are used to make solutions isotonic with the body fluids. Many drugs are prone to oxidation and to protect them,antioxidants are used.
Methods to prevent oxidation: Removing the oxygen present in the soil by passing the inert gas. A nd the concentration of parenterals should be enough that they should not allow micro organisms development when the product is drawed and during the usage. 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.
Drug absorption, distribution, metabolism and excretion has to be considered while deciding the type of formulation. Modified dosage forms are used in the case of drugs having rapid absorption, distribution, metabolism and secretion. If the drug is moved rapidly from the site of injection, viscosity enhancers should be added to slow down the movement. Freeze dryingis employed in case of drug that degrade when they remain in solution form.
If the drug stored in cold conditions, care must be taken that the drug is soluble at low temperatures. Development of Subclavian vein cannulation- infused fluid is rapidly diluted by the high blood flow in the subclavian vein.
Are typically electrolyte solutions, where electrolyte composition is intended to maintain diastolic arrest. The process is employed to counteract some forms of drug or chemical toxicity as well as to treat acute renal insufficiency. An antibiotic is often added to these solution as a prophylactic measure. Although certain IV solutions, such as normal saline, may be used as irrigating solutions should not be used parenterally.
The quality of parenterals is the sum of all parameters that contribute to safety, efficacy and therapeutic efficacy of the drug. The USP compendial requirements has recommended the following tests for parenteral products 1. Weight variation or content uniformity 2.
Particulate matter in injections 3. Bacterial endotoxin test 4. This test is intended for sterile solids used for parenteral preparation. The weight of 10 individual sterile units is noted and the content is removed from them and empty individual sterile unit is weighed intern. Then net weight is calculated by subtracting empty sterile unit weight form gross weight.
The content of active ingredient in each sterile unit is calculated by performing the assay according to the individual monographs.
The content in 10 sterile units is calculated by performing the assay. The dose uniformity is met if the amount of active ingredient is within the range of If one unit is outside the range of The preparations intended for parenteral use should be free form particulate matter and should be clear when inspected visually. Two methods are described by USP according to the filled volume of the product to be tested.
LAL Limulus Amebocyte Parenteralx test is used to characterize the bacterial endotoxin that may be present.
The LAL reagent is used for gel-clot formation. The test is performed using stated amounts of volumes of products, standard, positive control, negative control of endotoxin. When the tubes are inverted at C angle, formation of firm gel confirms positive reaction.
It is performed by using rabbits as test animals. The temperatures are recorded at 1, 2 and 3 parenteras after injection.
If any one rabbit larbe a rise in temperature of 0. The requirements are met if 3 out of 8 rabbits shows an individual rise in temperature of NMT 0. Growth promotion medium and incubation conditions are selected based on the test microorganism according to USP and is listed in table 1. The sterility test is done using direct transfer and membrane filtration techniques.
Membrane filtration technique is suitable for liquids, soluble powders with bacterio ladge or fungi static properties, oils, creams and ointments. Sterility test by direct transfer is performed by aseptic transfer of specified volume from test container foormulation 2 to culture medium and incubated for 14 days and visual observation of medium is done on 3 rd4 th5 th7 th8 th and 14 th day.
A membrane filter with porosity parentetals 0. The test meets the requirements when no growth is observed and if growth is observed then the test is repeated in the second stage and generally second stage is repeated with double the number of specimens tested in first parenterald when the test was found to be conducted under faulty or inadequate aseptic techniques.
Liquid quantities for USP sterility test. Hanna SA, Quality Assurance. Plastic containers are meant for using to packing of various types of sterile dosage forms which includes ophthalmic preparations, infusion and dialysis fluids and forulation injections. Plastic containers are made up with thermoplastic polymers of high molecular weight 1.
Plastic containers exhibits some advantages over glass containers, which includes 1. Plastic containers are selected on the basis of physical and chemical properties of parenterwls types of plastic used in its manufacture. Fexible polyethylene containers are used for ophthalmic solutions to be administered in drops.
All of plastic materials excluding low density polymers are an be sterilized by autoclaving. The reaction from the test sample must not be significantly greater than non reactive control samples.
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It is a liquid preparation consisting of drug. Cosolvents are used if the drug is not completely soluble in water. Parenteral dosage form has a wide range of specialized large-volume solution.
Few important are explained over here. Weight vopume or content uniformity test This test is intended for sterile solids used for parenteral preparation. Particulate matter in injections The preparations intended for parenteral use should be free form particulate matter and should be clear when inspected visually.