Parenterals: Compounding Sterile Formulations Chapter 9 Pgs.250-283

What is/are Parenterals? Most commonly refers to medicines administered through syringes and intravenous sets. Can also include dialysis solutions and irrigation solutions.

Special requirements for how products are made, packaged, and administered. Solutions MUST be sterile!!! pH of IV solution should be about 7.4 Free of all visible particulate material. IV solutions should have an osmotic pressure similar to blood Pyrogen-Free Stable for its intended use

Why need to be sterile? Rapid access to circulatory system and can cause harm if infection develops. Must use aseptic techniques during compounding.

LVP Solutions (Large Volume) Container holds 100 mL or more Common uses: Solutions s additives for electrolyte/ fluid correction Nutrition Administering medications Common sizes: 100, 250, 500, and 1000 mL

LVP cont. Three types of containers: Glass bottle with air vent tube, glass bottle without air vent tube, and plastic tube. Container will have 2 ports on one end. An administration port to connect to tubing. Medication port so medicines can be added to LVP.

Discussion of CSP and USP <797> regulations on compounding noted on pages 254 and 255

Plastic Bags vs. Glass Plastic Bags Do not break Weigh less Require less space for storage and disposal Not vented to outside air, so bag collapses as solution administered. ***Some drugs/ solutions can not be used with plastic because they interact with the plastic.

Common LVP Solutions NS: sodium chloride solution D5W: dextrose 5% in water solution Ringer’s: Ringer’s solution LR: lactated ringer’s Various combinations of different strengths of sodium chloride and dextrose solutions also available.

SVP Solutions Packaged products that are either directly administered to a patient or added to another parenteral formulation. When added to another parenteral it is referred to as an additive and the final mix is an admixture.

Types of SVPs Ampule Vial Minibag Prefilled syringe

Ampules Elongated, sealed glass containers with a neck that must be snapped off. Most are weakened around the base – will have a colored band. Once ampule is opened becomes open- system container.

Vials Has a rubber stopper through which a needle is inserted to withdraw or add to the contents. Before withdrawing solution, an equal volume of air is usually drawn up in syringe and injected into the vial. May be prepared for single or multidose use.

Minibags Made of the same plastic materials as LVPs and same solutions. Just smaller in size, contain only 50-100 mL.

Special Solutions TPN Dialysis Solutions Irrigation Solutions

TPN (Total Parenteral Nutrition) Complex admixtures used to provide nutritional support unable to take in adequate nutrients through their digestive tract. They are hypertonic solutions and generally 2,000 to 3,000 mL solutions. Base solution is an amino acid and dextrose solution. Fat emulsions can be added; resulting solution is referred to as a TNA ( total nutrient admixture).

Dialysis Solutions Peritoneal Dialysis These are hypertonic solutions; so water will not move into the circulatory system. The toxic substances will move into the dialysis solution. Administered several times a day into abdominal cavity; remains in cavity 30-90 minutes and then drained. Solutions supplied as 2,000 mL or larger

Irrigation Solutions Not administered directly into veins but subject to same stringent controls. Containers are larger than 1,000 mL and designed to empty rapidly. Surgical solutions are usually NS or Sterile H2O; used to: bathe/ moisten body tissues, moisten dsgs, and/or wash instruments. Urological solutions used to maintain tissue integrity and remove blood Other common used solutions: Glycine 1.5% and Sorbitol 3% r/t being nonhemolytic. Page 259

Administration Devices Administration Sets Usually flexible plastic tubing May have air vents, filters, or a flashball. Drip chambers and tubing length can vary in size. Controllers/ Pumps used to regulate flow rate, can program medications into “Smart” pumps. Volume Control Chambers plastic cylinder that holds a desired amount of fluid to be delivered. IV Catheters one to five inches of plastic, with a needle inside that is removed after insertion.

Positive Pressure Pumps Cassette Pumps Elastomeric Pumps Syringe Pumps Peristaltic Pumps Piggy backs Heparin Locks

Laminar Flow Hoods pg. 264 Used to establish and maintain an ultraclean work area. HEPA filter used in hood will remove 99% of particles larger than 0.3 microns. According to USP <797> must maintain an ISO Class 5 environment when preparing sterile parenteral preparations.

The air can enter the hood/ filter from the bottom, top, or back. Two types of flow hoods. Horizontal flow hood Air enters the work area in a horizontal direction. Vertical flow hood Air enters the work area in a vertical direction. The air can enter the hood/ filter from the bottom, top, or back. Pg.265

Biological Safety Cabinets Many different types These take air into cabinet through work surface vents and recirculate it through a HEPA filter. Protect both personnel and environment from contamination. Use while working with cytotoxic and hazardous drugs.

Clean Rooms Area where Laminar Flow Hoods and Safety Cabinets MUST be housed. Isolated area away from the pharmacy’s main traffic. Regulations from USP <797> have mandates for standard requirements. Must be an ISO Class 7 environment. Preparing and cleaning instructions on pg. 267

Aseptic Techniques Sum total of methods and manipulations required to minimize the contamination of sterile products. Includes positioning of materials, clothing, sanitation procedures, and supply collection Need to sterilize puncture surfaces; use a new alcohol wipe when wiping each surface. Avoid excess alcohol or lint that might be carried into the solution.

Pages 270-274 provide information on working with ampules and vials. Opening, mixing, and transferring solutions.

Syringes and Needles Multiple types of syringes available depending on need. Vary in size; 1- 60 mL. Needle sizes are indicated by length and gauge. Length of the needle is in inches, from where the shaft meets the hub to the tip of the bevel. The gauge is the size of the needle lumen; 27 (smallest)- 13 (largest).

Filters Used to remove particulate materials or microorganisms from solutions. Two main types: depth and membrane. Depth: traps particles as solution moves through twisting channels. Membrane: contains many small pores that retain particles larger than the pores. Another, less common is a final filter. Solution enters filter immediately before entering patient’s vein.

Quality Assurance and Infection Control information can be located on pages 278/ 279. Parenteral incompatibilities on page 280 Factors affecting incompatibility page 281 Units of Measurement (concentration of a drug in a parenteral solution) page 282/ 283.