logging in or signing up LARGE VOLUME PARENTERALS arvindkumar36 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 366 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: April 27, 2013 This Presentation is Public Favorites: 0 Presentation Description LVPs(introduction,manufacturing,batch mixing,filter) Comments Posting comment... Premium member Presentation Transcript A SEMINAR ON: 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 2012-2013INTRODUCTION: 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 agentPowerPoint Presentation: Tonicity adjuster Inorganic salts – Na , K Alkaline earth metals – Ca ,Mg Stabilizer & Antioxidants EDTA , Bisulphite , metabisulphiteSTABILITY: 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 & containerReceiving: 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: 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 .PowerPoint Presentation: 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 USPPowerPoint Presentation: (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 USPPowerPoint Presentation: (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 )PowerPoint Presentation: Membrane filter The separation of suspended solid from lipid by filtration can be divided into 3 basic mechanism – SCREEN FILTER DEPTH FILTER CAKE FILTERPowerPoint Presentation: SCREEN FILTERPowerPoint Presentation: DEPTH FILTERPowerPoint Presentation: DEPTH FILTERPowerPoint Presentation: CAKE FILTER You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.