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LVPs(introduction,manufacturing,batch mixing,filter)


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A SEMINAR ON LARGE VOLUME PARENTERALS Presented to Mr. AMIT PORWAL (Asstt. professor) School of pharmacy presented by SANDEEP SINGH M.pharm . (II SEM) Pharmaceutics 2012-2013


INTRODUCTION The united state pharmacopoeia defined the large volume injections as product in container labelled as more than 100 ml of single dose injection for administration by intravenous infusion.

Manufacture of LVP:

Manufacture of LVP Raw materials Commonly used carbohydrates are –  Monosacharides (dextrose , fructose)  Diasaccharides (sucrose , maltose)  Polysaccharides( dextran ) Nitrogen containing substances –  Lipid Emulsion required vagitable oil Polyols Glycerol  tonicity adjuster Sorbitol  irrigation product Manitol  osmotic agent

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Tonicity adjuster  Inorganic salts – Na , K Alkaline earth metals – Ca ,Mg Stabilizer & Antioxidants  EDTA , Bisulphite , metabisulphite


STABILITY Appropriate programe needed to qualify each material used but it also access oter parameter like  Insoluble particulate level  Filterability of solution containing the material  Physical attributes (particle size & crystalinity )  Presence of contaminants & degradants  High or Low pH solution may precipitate Aluminium compound  Heat , light , air moisture & container


Receiving  All raw material & container must be inspected,identified documented & sampled in according with written procedure.  Raw material should be issued on “First- In/First-out” (FIFO) basis.  Also record receiving date, Stockno . , manufacturing date,vendor ID no. , expiration date.  Completed documentaion & tracebility maintain.  Material receive in cover & closed container.


Storage  All material associated with final drug product( container,closure,drug substances) tested according to written specification.  During testing interval material kept in Qurantine area.  Different area for Rejected , Accepted , Unrelesed materials.  Status of material should be clearly identified  This secured area should be locked when not in use.

Inventory Control:

Inventory Control  In inventory materials location & quantity must be known.  Receiving report identify each items by stock no.,name,vendor,accountability tag.  Operator should record the drug used destination, quantity withdrawl .  When continer is emptied accountability tag is removed & send to R.M. accountability function for reconcilation .  Periodic inventory are made indicating the quantity remaining for each lot of r.m .

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Batch Mixing (A) Simple solution  with exception of o/w emulsion used for parenteral nutrition , the majority of large LVP are simple aq. Solution of electrolyte,amino acid or sugars. Example – Lactated Ringer’s 5% dextrose inj. USP Dextrose hydrous USP Nacl USP Sodium Lactate USP KCl USP Calcium Chloride USP Water For injection USP

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(B) Lipid Emulsion  The production of lipid emulsion is highly specilized process because difficulty dealing with dispersed system in which average droplet diameter is reqyuired below 500 nm.  Thermodynamically unstable. Difficulty in heat sterilization. Example- 10 % i.v . Fat emulsion fractionated soy oil fractionated egg phosphatides glycerol USP water for injection USP

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(C) Specialized product  Specialized LVP containing active ingredient that are not adequately stable in solution or compatible with container when reconstituted as aq. Solution Example Tris amino physiological buffer, urea,an osmotic diuretics in this substance . The active ingredient provideed as sterile nonpyrogenic solid with a separate compnion diluent (e.g. sterile urea solid for injection with a corbohydrate diluent )

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Membrane filter The separation of suspended solid from lipid by filtration can be divided into 3 basic mechanism –  SCREEN FILTER  DEPTH FILTER  CAKE FILTER

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