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434 PHT Sterile Dosage Forms Nahla S. Barakat, Ph.D King Saud University College of Pharmacy Dept. of Pharmaceutics 1432-1431 5/11/20151434 PHT.

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Presentation on theme: "434 PHT Sterile Dosage Forms Nahla S. Barakat, Ph.D King Saud University College of Pharmacy Dept. of Pharmaceutics 1432-1431 5/11/20151434 PHT."— Presentation transcript:

1 434 PHT Sterile Dosage Forms Nahla S. Barakat, Ph.D King Saud University College of Pharmacy Dept. of Pharmaceutics /11/ PHT

2 5/11/ PHT2 Introduction and characteristics of sterile dosage forms. Methods of sterilization Composition of Sterile Dosage Forms. Large Scale preparation of Sterile Products. Handling and Administration. Large Volume Sterile Solutions. IV Admixtures and incompatibilities. Ophthalmic preparations. The course topics Reference: Sterile dosage forms, preparation, clinical application. Salvatore Turco. 1996

3 5/11/ PHT3 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 ons - Peritoneal dialysis solutions

4 5/11/ PHT4 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

5 5/11/ PHT5 Intradermal (23) Intravenous (21) Intramuscular (20) Subcutaneous (21) Intra arterial (20-22)

6 5/11/ PHT6 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

7 5/11/ PHT7 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

8 5/11/ PHT8 Formulation of Parenteral: 1.Therapeutic agents 2.Vehicles i.Water ii.Water miscible vehicles iii.Non- aqueous vehicles 3.Added substances (Additives) i.Antimicrobials ii.Antioxidants iii.Buffers iv.Bulking agents v.Chelating agents vi.Protectants vii.Solubilizing agents viii.Surfactants ix. Tonicity- adjusting agents

9 5/11/ PHT9 IV ComponentAbbreviation 2.5% dextrose in waterD 2.5 W 5% dextrose in waterD5WD5W 5% dextrose and lactated Ringer’s solution D 5 RL or D 5 LR 10% dextrose in waterD 10 W 5% dextrose and normal salineD 5 NS 2.5% dextrose and 0.45% normal salineD 2.5 ½ NS 5% dextrose and 0.45% normal salineD 5 ½ NS Commonly Used IV Abbreviations Fluids

10 5/11/ PHT10 IV ComponentAbbreviation Normal salineNS 0.45% normal saline0.45%NS or ½ NS lactated Ringer’s solutionRL or LR sterile water for injectionSWFI bacteriostatic water for injectionBWFI sterile water for irrigationSW for irrigation normal saline for irrigationNS for irrigation Commonly Used IV Abbreviations: Fluids

11 5/11/ PHT11 IV ComponentAbbreviation potassium chlorideKCl potassium phosphateK phos or KPO 4 potassium acetateK acet sodium phosphateNa phos or NaPO 4 sodium chlorideNaCl Commonly Used IV Abbreviations: Electrolytes

12 5/11/ PHT12 IV ComponentAbbreviation multivitamin for injectionMVI trace elementsTE zinc (a trace element)Zn selenium (a trace element)Se Commonly Used IV Abbreviations: Additives

13 5/11/ PHT13 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 ampoule into 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.

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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 5/11/ PHT15

16 5/11/ PHT16 1 2

17 5/11/ PHT17 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 Mix-O-Vial (Upjohn) Double chambered vials

18 5/11/ PHT18 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.

19 5/11/ PHT19 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.

20 5/11/ PHT20 Syringe tips: i- Luer-Lok Tip ii- Luer-Slip Tip iii- Eccentric Tip iv- Catheter Tip i ii iv iii

21 5/11/ PHT21

22 5/11/ PHT22 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

23 5/11/ PHT23 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.

24 5/11/ PHT24 The Needle:

25 5/11/ PHT25 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

26 5/11/ PHT26 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 1 1/ /2 in Intracardiac 3 1/2 in

27 5/11/ PHT27 Needle gauge: is the outside diameter 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 G S.Q require G (insulin) IM require G Compounding Parenteral G

28 5/11/ PHT28

29 5/11/ PHT29 The French catheter scale or "French units" (F) is commonly used to measure the outside diameter of needles, catheters, and other cylindrical medical instruments.French catheter scalediameterneedlescatheters 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.

30 5/11/ PHT30 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 by or on the order of a physician.”

31 5/11/ PHT31 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

32 5/11/ PHT32 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

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34 5/11/ PHT34 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  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 ).

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.median cubital vein Often it is necessary to use a tourniquet which restricts the venous drainage of the limb and makes the vein bulge.tourniquet 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.extravasation 5/11/ PHT35

36 5/11/ PHT36

37 5/11/ PHT37 Different Types of IV Containers

38 5/11/ PHT38 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

39 5/11/ PHT39 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 Prefilters in the laminar -airflow hood will be cleaned monthly.

40 5/11/ PHT40 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.

41 5/11/ PHT41 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.

42 5/11/ PHT42 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

43 Peripheral IV injection This is the most common intravenous access method in both hospitals and pre-hospital services. hospitalspre-hospital 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). Arms and hand veins are typically used.peripheral IV linecatheterperipheral vein 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. 5/11/ PHT

44 Venflon intravenous cannula 5/11/ PHT

45 5/11/ PHT45 Parts of I.V. cannula

46 Special consideration: The size of cannula effects four factor; Needle guage External diameter of cannula i.e. its catheter Length of catheter Flow rate i.e. ml/min As the gauge number increases the cannula size decreases (14 largest and 24 smallest) Larger the gauge number is (24G) smaller the cannula/diameter is (0.7mm) 5/11/ PHT46

47 5/11/ PHT47 Butterfly catheter — a metal needle with flexible plastic ‘wings’ and a short length of tubing. The ‘wings’ assist in placement and facilitate fixation with tape.

48 Central IV lines Central IV lines flow through a catheter with its tip within a large vein, usually the superior vena cava or inferior vena cava, or within the right atrium of the heart. Central IV linessuperior vena cavainferior vena cavaatrium This has several advantages over a peripheral IV: It can deliver fluids and medications that would be overly irritating to peripheral veins because of their concentration or chemical composition. These include some chemotherapy drugs and total parenteral nutrition.chemotherapytotal parenteral nutrition It is used when patients require long-term IV therapy. Multiple medications can be delivered at once. Medications reach the heart immediately, and are quickly distributed to the rest of the body. 5/11/ PHT

49 Central IV lines carry risks of bleeding, infection, gangrene, thromboembolism and gas embolism.gangrene thromboembolismgas embolism They are often more difficult to insert correctly as the veins are not usually palpable and rely on an experienced clinician knowing the appropriate landmarks and/or using an ultrasound probe to safely locate and enter the vein.ultrasound probe 5/11/ PHT

50 5/11/ PHT50 Methods of IV administration InjectionInfusion Intermittent Piggyback Manufactured reconstituted Frozen Liquids prefilled piggyback Partial fill Mini-infusion Volume control set Continuous

51 Methods of IV administration Continuous drip infusion: is the slow primary-line infusion of an IV preparation to maintain a therapeutic drug level or provide fluid and electrolyte replacement. This method achieve continuous, constant blood levels of the drug. In many instances, drug therapy is accomplished initially by IV push and then maintained slowly and constantly by IV infusion. 5/11/ PHT51

52 Intermittent infusion: allows drug administration at specific intervals (e.g., every 4 h). has a "high" infusion rate, alternating with a low programmable infusion rate to keep the cannula open. The timings are programmable. This mode is often used to administer antibiotics, or other drugs that can irritate a blood vessel.antibiotics Total parenteral nutrition usually requires an infusion curve similar to normal mealtimes. 5/11/ PHT52

53 Direct IV push (Bolus): The drug solution is administered in a short time directly into a vein. The injection time is a matter of minutes and varies with different drugs. Many drugs are given by IV push and are diluted further with the vehicle to reduce the irritability on the vein. Not all drugs may be pushed IV Phenytoin and diazepam injections must be given by IV push They much be pushed at a specified rate that is slow enough to prevent toxicity. 5/11/ PHT53

54 5/11/ PHT54 A piggyback is a small-volume parenteral admixture that is attached to an existing IV line The piggybacked solution is infused into the tubing of the running IV – usually over a short time, from 30 minutes to 1 hour Some IV piggybacks are prepared in 250 mL solution because they contain a medication that is irritating to the veins In some cases, syringes are used instead of piggyback containers to deliver medication into a running IV

55 Benefits of intermittent infusion:  The method is suitable for patients who don not require administration of large amounts of IV fluids.  It permits greater patient ambulation, as the intermittent infusion injection devices do not require continuous attachment to an IV bottle or bag. 5/11/ PHT55

56 5/11/ PHT56 Preparing a Label for an IV Admixture Labels for IV admixtures should bear the following information: – patient’s name and identification number – room number – fluid and amount – drug name and strength (if appropriate) – infusion period – flow rate (e.g., 100 mL/hr or infuse over 30 min) – expiration date and time – additional information as required by the institution or by state or federal guidelines

57 Pumps are electronic devices used to administer parenteral infusions when the use of gravity flow alone might lead to inaccurate dosing or risk patient safety. Pumps are used to administer parenteral nutrition, chemotherapy, cardiac medications and blood products. Types of pump There are two basic classes of pumps. Large volume pumps can pump nutrient solutions large enough to feed a patient. Small-volume pumps infuse hormones, such as insulin, or other medicines, such as opiates.hormonesinsulinopiates Within these classes, some pumps are designed to be portable, others are designed to be used in a hospital. 5/11/ PHT57

58 Benefits of pumps: They maintain a constant, accurate flow rate They detect infiltration, occlusions and air Pumps decrease the time of a nurse spends dispensing medications 5/11/ PHT58

59 Types of pumps: 1- Volumetric pump: are used for intermittent infusion of medications such as antibiotics, also used for continuous infusion of IV fluid, Parenteral nutrition 2- Syringe pump: are used to administer intermittent or continuous infusion of medication in concentrated form 3- Mobile infusion pump: is small device designed for ambulatory and home patients, used for chemotherapy, and opiate medications 4- Implantable pump: are infusion device surgically placed under the skin to provide a continuous release of medication, typically an opiate, this type has a lower index of infection 5/11/ PHT59

60 5/11/ PHT60 5-patient-controlled analgesia5-patient-controlled analgesia (PCA), in which repeated small doses of opioid analgesics are delivered on demand, with the device coded to stop administration before a dose that may cause hazardous respiratory depression is reached.opioidanalgesics


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