Small/Large-Volume LVP, SVP—[Mfg.:Taj Pharma—Direct line: +91 8448 444 095/Mail: info@tajpharma.com]

Small/Large-Volume LVP, SVP—[Mfg.:Taj Pharma—Direct line: +91 8448 444 095/Mail: info@tajpharma.com]

A large volume parenteral (LVP) is a unit dose container of greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all" for all non-LVP parenterals products except biologicals.

#SmallVolumeParenteral #SVP #LVP #LargeVolumeParenteral

An Introduction to Large Volume Parenterals (LVPs) as a Pharmaceutical Dosage Form and

an E&L Challenge

Parenteral Dosage Forms Parenteral drug products are injected through the skin or other external boundary tissue, or implanted within the body, to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Parenteral dosage forms include solutions, suspensions, emulsions, sterile powders for solutions and suspensions (including liposomes), implants (including microparticles), and products that consist of both a drug and a device such as drug-eluting stents. Routes of Parenteral Administration • Intravenous injections and infusions • Subcutaneous injections • Intramuscular injections • Intradermal injections • Intra-arterial injections • Intra-cardic injections • Intraspinal injections • Intra-articular injections Classification of Parenteral Preparations Based on Type of Packaging: ➢ Single dose units: ampoules, infusions, pre-filled disposable syringes ➢ Multiple dose units: multiple dose vials Based on Fill Volume: ➢ Small volume parenteral (SVP): volume 100 mL ➢ Large-volume parenteral (LVP): volume 100 mL Characteristics of LVPs Packaged in glass bottles or in large volume flexible containers. ➢ May contain greater than 100 mL to greater than 1 or 2 L ➢ Sterile (e.g., many LVP are sterilized in their container via heat, although some are sterile-filled) ➢ Pyrogen-Free ➢ Essentially free of particulate matter ➢ No anti-microbial agents ➢ Isotonicity ➢ Longer term use ➢ Electrolytes (Cardioplegia) ➢ Carbohydrates ➢ Nutritional (Hyper-alimentation)Solutions–Proteins– Lipid Emulsions ➢ Peritoneal Dialysis ➢ Irrigating Solutions ➢ Blood derivatives (e.g. albumin) ➢ Drug Premixes ➢ Contrast agents Materials of Construction for Flexible LVP Packaging • Polyethylene (PE) • Polypropylene (PP) • Poly vinyl chloride, plasticized (PVC) • Polyamide (Nylon) • Polycarbonate (PC) • Ethylene vinyl acetate (EVA) • Polyolefin (layered structures of PE, PP, EVA and Nylon) • Elastomers Advantages and Disadvantages of Flexible Containers for LVPs Advantages ➢ Durable. ➢ Light weight. ➢ No air interchange. The bag collapses as it empties. Disadvantages ➢ Permeation of vapors and other molecules in either direction through the walls. • Resolved by overwrapping the containers ➢ Leaching of constituents from the plastic into the product. • Plasticizers, anti-oxidants, other additives ➢ Sorption of drug molecules or ions on the plastic material. • Proteins, warfarin sodium, Distribution of Large. Volume Parenterals (LVP's) in various states of India * फार्मास्यूटिकल प्रोडक्ट / Large Volume Parenterals Plastic Bottles. Direct line: +91 8448 444 095 Toll free: 1-800-222-434 Toll free: 1-800-222-825 General EPA BX: +91 22 2637 4592 +91 22 2637 4593 Fax No.:+91 22 2634 1274 E-Mail: info@tajpharma.com Small Volume Parenteral (SVP) solutions are usually Less than 100 ML and are packaged in different ways depending on the intended use . The Importance of Large-Volume Parenterals (LVPs)

Drugs administered as parenteral solutions are prepared as either small-volume or large-volume products. Large-volume parenterals (LVPs) include intravenous solutions sold in bags or bottles containing 100 mL or greater (250 mL, 500 mL, 1 L). They are packaged in these large volumes because larger quantities are typically required. Common LVPs include solutions needed to correct electrolyte and fluid imbalances, provide important nutrients or act as a vehicle for the delivery of other drugs. The most common examples include sodium chloride solution, dextrose solution, Ringer's solution, and lactated Ringer's solution, as well as combinations of dextrose and sodium chloride. The market for LVPs is expanding due to an increase in the numbers of surgeries performed and the growing numbers of patients with chronic and other lifestyle-related diseases requiring hospitalizations.1 LVPs provide a faster method for administering drugs to patients during surgery and when in the hospital. A growing preference by patients for single-dose administration of vaccines and drugs to treat chronic diseases is also driving demand for LVPs.