434 PHT Sterile Dosage Forms Nahla S. Barakat , Ph.D King Saud University

1. 434 PHT Sterile Dosage Forms Nahla S. Barakat, Ph.D King Saud University College of Pharmacy Dept. of Pharmaceutics1432-1431 434 PHT

2. The course topics Reference: Sterile dosage forms, preparation, clinical application. Salvatore Turco. 1996 434 PHT

3. Sterile products: Sterile dosage form refers to a product of a general group of pharmaceuticals having in common the characteristic of sterility, i.e., freedom from living microorganism The sterile dosage forms in general use: - Injections - Infusion fluids - Radiopharmaceuticals - Sterile solids - Sterile suspensions -Ophthalmic solutions, suspensions, and ointments -Solution for irrigation - Diagnostic agents - Peritoneal dialysis solutions 434 PHT

4. Parenteral products are dosage forms intended for administration by injection, infusion or implantation. Major routes of Parenteral administration: Intradermal Subcutaneous Intramuscular Intravenous Intra-arterial Intraspinal Intra-articular Intracardiac Hypodermoclysis 434 PHT

5. Subcutaneous (21) Intravenous (21) Intradermal (23) Intramuscular (20) Intra arterial (20-22) 434 PHT

6. Official Types of Injections: 1. Solutions of Medicinal Example: Codeine Phosphate Injection Insulin Injection 2. Dry solids or liquid concentrate does not contain diluents etc. Example: Sterile Ampicillin Sodium 3. If diluents present, referred to as.....for injection Example: Methicillin Sodium for injection 434 PHT

7. 4. Suspensions "Sterile....Suspension" Example: Sterile Dexamethasone Acetate Suspension 5.Dry solids, which upon the addition of suitable vehicles yield preparations containing in all respects to the requirements for sterile suspensions. Title: Sterile....for Suspension Example: Sterile Ampicillin for Suspension 6. Injectable Emulsions: Example: Propofol injection 434 PHT

8. Formulation of Parenteral: • Therapeutic agents • Vehicles • Water • Water miscible vehicles • Non- aqueous vehicles • Added substances (Additives) • Antimicrobials • Antioxidants • Buffers • Bulking agents • Chelating agents • Protectants • Solubilizing agents • Surfactants ix. Tonicity- adjusting agents 434 PHT

9. Commonly Used IV AbbreviationsFluids 434 PHT

10. Commonly Used IV Abbreviations:Fluids 434 PHT

11. Commonly Used IV Abbreviations:Electrolytes 434 PHT

12. Commonly Used IV Abbreviations:Additives 434 PHT

13. Liquid drugs are supplied in prefilled syringe, heat-sealed ampoules, vials sealed with rubber closure. • Ampoules are intended for single dose only, do not provide dose flexibility. • A 5 micron filter needle should be used when drawing the contents of an ampouleinto a syringe since glass particles may have fallen inside the ampoule when the top was snapped off. • It is useful to wrap an alcohol wipe or small piece of gauze around the top of the ampoule before breaking it. 434 PHT

14. 2 1 3 434 PHT

15. Vials may be designed for single-dose or multi-dose use (contain preservative). Glass or plastic container • Advantages: • The product is easier to remove from vials than form ampoules. • The vials can hold multiple doses. • Eliminate the risk of glass particles contamination during opening. • Some drugs are not stable in liquid form and so are put into the powder form and reconstituted before use. • Disadvantages: • The rubber stopper can become cored causing a small bit of rubber to enter the solution. • Possible error in dose calculation • Increased waste • Increased microbial contamination 434 PHT

16. 1 2 434 PHT

17. Double chambered vials Mix-O-Vial (Upjohn) • Can be used to package a sterile powder with its vehicle. • The top chamber contain sterile water for injection, is separated from the bottom chamber holding the sterile powder by a rubber plug located at the constriction of the container. • External pressure is applied to the outer rubber closure to dislodge the inner closure and mix the contents of the components. Ex.: Solu-Cortef, kefzol. • A convenient way to separate unstable drug from the diluent 434 PHT

18. Prefilled disposable cartridge or syringes: • Are designed for maximum convenience. The injection is filled into a glass cartridge with needle attached and administered with a reusable stainless steel or plastic holder. • The other type of prefilled syringe consists of a glass tube closed at both ends with rubber stoppers. The prefilled tube is placed into a specially designed syringe that has needle attached to it. • After using this type of prefilled syringe, all of the pieces are discarded. 434 PHT

19. Advantages: Ease of administration, reduction of medication error, increase assurance of sterility, good control of drugs (narcotics), adequate labeling save nurses' time. Emergency drugs as: Sodium bicarbonate, epinephrine, Ca chloride, lidocaine, atropine are available for use as IV in this type of prefilled syringe. 434 PHT

20. i ii Syringe tips: i- Luer-Lok Tip ii- Luer-Slip Tip iii- Eccentric Tip iv- Catheter Tip iv iii 434 PHT

21. 434 PHT

22. Intravenous Access Devices Syringes: are devices for injection, withdrawing fluids. Syringes consist of glass or plastic barrel with a tight-fitting plunger and tip provides the point of attachment for a needle. The barrel is graduated in milliliters. Glass reusable, glass disposable, plastic disposable. Syringe volume: 1-60 ml 434 PHT

23. Insulin syringe is graduated in units of insulin (40, 80, 100 unit/ml) • Tuberculin syringes have capacity of 1 ml, a volume of 0.05 ml can be measured with accuracy. 434 PHT

24. The Needle: Transfer needle 16 and 19 gauge thin-wall needles for fluid transfer from a unit-of-use vial to a bag or evacuated IV bottle 434 PHT

25. Different bevels: are slanting edges cut into needle tips Regular bevel: used for IM and SC Short bevel: used for IV and intraspinal True short bevel: used for intradermal administration 434 PHT

26. Various needle lengths are available: range from 1/4 to 6 inches (in). • The choice depends on the site of administration, the depth of penetration into the body. • Compounding parenteral 1 1/4 in • IM 1-2 in • I.D , SQ 1/4 - ⅝ in • IV infusion 11/4 - 2 1/2 in • Intracardiac 3 1/2 in 434 PHT

27. Needle gauge:is the outsidediameter of the needle shaft. • Gauge in common range from 13-to 27. • The choice of gauge depends on the viscosity of the fluid to be injected or withdrawn. • Intradermal require 24-26 G • S.Q require 24-25 G (insulin) • IM require 19-22 G • Compounding Parenteral 18-20 G 434 PHT

28. 434 PHT

29. The French catheter scale or "French units" (F) is commonly used to measure the outside diameter of needles, catheters, and other cylindrical medical instruments. In the French system, the diameter in millimeters of the catheter can be determined by dividing the French size by 3. D(mm) = F/3 or F = D(mm) * 3 For example, if the French size is 9, the diameter is 3 mm. 434 PHT

30. IV Sets • An IV administration set is a sterile, pyrogen-free disposable device used to deliver IV fluids to patients • The set may be sterilized before use by means of radiation or ethylene oxide • The set come in sterile packaging and a sealed plastic wrap • Sets carry expiration dates • Sets carry the following legend: • “Federal law restricts this device to sale on the order of a physician.” 434 PHT

31. Each unit is supplied in packaging that ensures the maintenance of sterility • Flanges and other rigid parts of an IV set are molded from tough plastic • Most of the length of the tubing is molded from a polyvinyl chloride (PVC) • PVC sets should not be used for • nitroglycerin, which is absorbed by the tubing • IV fat emulsions, which may leach out of the tubing 434 PHT

32. The length of sets varies from 6-inch extensions up to 110- to 120-inch sets used in surgery • the priming of tubing depends on the length of the set • Standard sets have a lumen diameter of 0.28 cm • varying the size of the lumen diameter achieves different flow rates • regulation of flow rates is critical in neonates and infants 434 PHT

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34. Intravenous administration set: • Plastic spike to pierce the rubber closure or plastic seal on the IV container • A drip chamber to trap air and permit adjustment of flow rate • 150-450 cm length polyvinyl chloride tubing terminating in • A gum-rubber injection port ending with rigid needle or catheter adapter • An adjustable clamp (screw or roller type) on the tubing to regulate flow • Air-inlet filters designed as part of the administration set (used with glass container that have no air tubes ). 434 PHT

35. The most convenient site is often the arm, especially the veins on the back of the hand, or the median cubital vein at the elbow, but any identifiable vein can be used. • Often it is necessary to use a tourniquet which restricts the venous drainage of the limb and makes the vein bulge. • Once the needle is in place, it is common to draw back slightly on the syringe to aspirate blood, thus verifying that the needle is really in a vein. The tourniquet should be removed before injecting to prevent extravasation of the medication. 434 PHT

36. 434 PHT

37. Different Types of IV Containers 434 PHT

38. Preparing IV solutions • Preparation should always be done under the supervision of a licensed pharmacist • Medication that is prepared by the technician must be reviewed and approved by the pharmacist 434 PHT

39. Begin any IV preparation by washing your hands thoroughly using a germicidal agent such as chlorhexidine gluconate or povidone-iodine • All jewelry should be removed from the hands and wrists before scrubbing and while making a sterile product • Wear gloves during procedures • Laminar airflow hoods are normally kept running • The exterior surfaces of the hood should be disinfectant weekly with 70% isopropyl alcohol. • Before making the product, thoroughly clean all interior working surfaces using sterile gauze with 70% isopropyl alcohol • Prefilters in the laminar -airflow hood will be cleaned monthly. 434 PHT

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41. Eating, drinking, talking, or coughing is prohibited in the laminar airflow hood • Working in the laminar flow hood should be free from interruptions • Gather all the necessary materials for the operation and make sure they are: • not expired • free from particulate matter such as dust • check for leaks by squeezing plastic solution containers • Only essential objects and materials necessary for product preparation should be placed in the airflow hood. 434 PHT

42. Work in the center of the work area within the laminar airflow hood • at least six inches inside the edge of the hood • make sure nothing obstructs the flow of air from the high-efficiency particulate air (HEPA) filter over the preparation area • nothing should pass behind a sterile object and the HEPA filter. • Minimize hand movements within the hood. • Swab all surfaces require puncture with 70% isopropyl alcohol or betadine solution. 434 PHT

43. Follow proper procedure for handling sterile devices and medication containers • Remember that the plunger and tip of the syringe are sterile and must not be touched • For greatest accuracy, use the smallest syringe that can hold the desired amount of solution • syringe should not be larger than twice the volume to be measured • Examine all formulations before removing them from the hood • Place all syringes and needles in puncture-proof containers 434 PHT

44. Follow proper procedure for handling sterile devices and medication containers • Remember that the plunger and tip of the syringe are sterile and must not be touched • For greatest accuracy, use the smallest syringe that can hold the desired amount of solution • syringe should not be larger than twice the volume to be measured • Examine all formulations before removing them from the hood • Place all syringes and needles in puncture-proof containers 434 PHT

45. Follow proper procedure for handling sterile devices and medication containers • Remember that the plunger and tip of the syringe are sterile and must not be touched • For greatest accuracy, use the smallest syringe that can hold the desired amount of solution • syringe should not be larger than twice the volume to be measured • Examine all formulations before removing them from the hood • Place all syringes and needles in puncture-proof containers 434 PHT

46. NEVER TOUCH Tip or Plunger 434 PHT

47. Peripheral IV injection • This is the most common intravenous access method in both hospitals and pre-hospital services. • A peripheral IV line consists of a short catheter (a few centimeters long) inserted through the skin into a peripheral vein (any vein that is not inside the chest or abdomen). Ex. Arms and hand veins are typically used. • The scalp veins are sometimes used in infants • This is usually preferred for drugs that don’t irritate the veins • Patients require short-term IV therapy • Administration of isotonic solutions. 434 PHT

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49. Peripheral venous catheters will likely cause problems 20 to 50% of patients • pain • irritation • infiltration • Infiltration is a breakdown or collapse of a vein that allows the drug to leak into tissues surrounding the catheter site, causing edema and/or tissue damage 434 PHT

50. Venflon intravenous cannula 434 PHT