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453 PHT. 2. Sterile productsSterile dosage form refers to a product of a general group of pharmaceuticals having in common the characteristic of sterility, i.e., freedom from living microorganismThe sterile dosage forms in general use:- Injections - Infusion fluids- Radiopharmaceuticals - Sterile solids- Sterile suspensions-Ophthalmic solutions, suspensions, and ointments - Solution for irrig9446
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1. 453 PHT 1 453 PHTHospital Pharmacy-II1428-1429N. S. Barakat, Ph.DKing Saud UniversityCollege of PharmacyDept. of Pharmaceutics
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3. 453 PHT 3 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 Intrasynovial
Intracardiac Hypodermoclysis
4. 453 PHT 4 The vehicle:
Water (SWFI)
Types of excipients:
Solvents and co-solvents
Oils of vegetable origin
Polymeric and surface-active compounds
Chelating agents
Antioxidants
Preservatives
Buffers
Bulking agents, protectants, tonicity adjusters
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12. 453 PHT 12 Parenteral Preparations
I- IV admixture: are consist of one or more sterile drug products added to an IV fluid. IV admixture are used for drug intended for continuous infusion or irritant drug or toxic drug.
II- IV fluid and electrolyte
Large volume solution for IV use:
a- Dextrose, 5D/W 2.5, 5, 10, 20, 50%
b- NaCL, N.S.S 0.9, 0.45, 3, 5%
bacteriostatic NaCL for injection
c- Ringer's solution (Na, K, Ca CL
d- Lactate Ringer's (+ Na lactate)
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14. 453 PHT 14 III- Electrolyte preparations
a- Cations
sodium, potassium, calcium, magnesium
b- Anions
chloride, phosphate, acetate
IV- Parenteral antibiotic preparations
Are sterile powders which must be reconstituted with sterile water, NS, 5D/W
May be given by direct IV injection; short-term infusion; IM, intrathecal.
V- Parenteral antineoplastic agents
May be given by direct IV injection; short-term infusion; long-term infusion, SC, IM, intrathecal.
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38. 453 PHT 38 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 ).
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43. 453 PHT 43 Intermittent infusion The drug is given at spaced intervals, in most often used for antibiotics.
For patients do not require administration of large amount of IV fluids.
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45. 453 PHT 45 Direct push (bolus) injection:
Small volume (1-50 ml) of drugs are injected into the vein over short period of time (1-5min) This method
achieve an immediate effect
Administer drug that cannot be diluted
Achieve a therapeutic serum drug level quickly.
Many drugs given by direct IV push are diluted further with the vehicle using a larger syringe. Not all drugs may be pushed IV.
For example: phenytoin, diazepam inj must be given by IV push
Gentamicin may not be given by push but must be given well diluted
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47. 453 PHT 47 Volume control method
Is appropriate for the intermittent delivery of small amount of IV solutions or diluted medications at controlled rates of flow.
It is calibrated plastic fluid chambers used as measuring device with the primary infusion bottles.
It provides means for critical measurement of infused fluid
It provides a vehicle for intermittent IV medication therapy.
Unstable drugs may be administered quickly in a minimum volume of fluid.
The chamber limit the volume of fluid that may be infused accidentally .
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49. 453 PHT 49 The piggyback method
i.e. the intermittent IV drip of a second solution, the reconstituted drug, through the venipuncture site of an established primary IV system.
It eliminate the need for another venipuncture also achieve drug dilution (hence, reduce irritation) and peak blood levels within a relatively short time (30-60 min).
Special set can be used:
A pressure sensitive valves that sense when the piggyback drug container is empty; the primary flow begins automatically, owing to a height difference between the primary fluid and piggyback drug containers. The primary container is hung lower than the secondary bottle by means of an extension hanger.
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52. 453 PHT 52 Prefilled partial-fill containers: Underfills, Mini-bottles: Partial-fill containers used for piggybacking are 250 ml capacity infusion bottles or bags underfilled with 50 or 100 ml of 5% D/W or normal saline solution.
The drug is first reconstituted in its original vial and then added by needle and syringe to the underfill which receives an administration set complete with needle.
The needle is inserted into the Y-site or gum rubber injection port of a hanging primary infusion set.
Flow of the primary IV fluid is stopped while the drug solution in the partial fill container is administered (30-60 min).
The primary fluid is reestablished.
When the next dose of drug is required, the piggyback procedure is repeated
53. 453 PHT 53 Prefilled piggyback units A mini-bottle (100 ml capacity) prefilled with a specific amount of dry drug (antibiotic).
A plastic bag or a plastic hanger for direct suspension from an IV pole.
The piggyback solution is administered through the gum rubber injection site or Y-type facility of an existing IV system.
Reconstitution of drug in a piggyback unit requires only addition of small volume of diluent.
No drug transfer is involved, transfer syringe and additional IV containers are not necessary
Great ease in handling, reduction in cost, patient safety, reduced potential for solution contamination.
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55. 453 PHT 55 premixes Frozen drug products packaged in PVC containers.
The frozen products are stored in a freezer in the hospital pharmacy and thawed and used when needed
Ex: Cefazolin, Cephalothin, cimetidine, cefotaxime.
Faspak/ADS-100 system:
Non-PVC plastic piggyback container, named Faspak, which contains the dry powdered form of certain drugs (kefzol, ampicillin, which upon reconstitution with appropriate diluent allow direct administration of the diluted drug.
This avoid a transferring step.
The Faspak acts as a final delivery container.
56. 453 PHT 56 ADD-vantage System Consist of two parts: a plastic IV bag sold by Abbot that is filled with solution, and a separate glass vial of powder or liquid drug sold by a drug maker.
The user locks the vial holding the drug into a chamber at the top of the plastic bag and mixes the drug and solution by externally remove the stopper on the vial.
Save labor and material costs and minimize drug waste.
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58. 453 PHT 58 Flow rates of IV infusion fluids Rate of flow of IV fluids is based on variety of factors:
Patient’s body area and age
Nomograms are used to calculate body SA
Composition of the fluid to be administered
Patient’s ability to assimilate the fluid.
The usual flow rate of low-viscosity isotonic solutions is app. 125ml/h or 1L / 8h
Highly hypertonic solutions are administered at a rate not exceeding
1L /8 h or 3L /24 h. (exception, blood loss, shock, the rate > 1L /1 ˝ h)
Order is written as KVO (keep vein open), i.e. the rate of
administration would be slow.
59. 453 PHT 59 The inverted IV container supported 1 meter above the patient. (gravity flow).
To determine the rate of flow requested, one must know the no of drops/ml delivered by the administration set.
Gravity flow is affected by the factors:
Variation in size of drip chamber orifice
Viscosity of solution
Patient’s blood pressure, movements
Height of IV container Clot formation, extravasations
Pressure change in IV container
Temperature and nature of solution
Y-set and multiple solutions
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61. 453 PHT 61 Pumps and controllers
Pumps are used to deliver IV infusion with optimum drug accuracy and safety. Two types of mechanisms are used:
Piston-cylinder mechanism: use a syringe like apparatus to pump the desired volume of fluid.
Linear peristaltic mechanism: use external pressure to expel the fluid out of the pumping chamber.
Volumetric pump: are used for intermittent infusion of medication (antibiotics), also used for continuous infusion of IV fluid, Parenteral nutrition, anti-asthma medication.
62. 453 PHT 62 Syringe pump: used with intermittent or continuous infusions of medications (antibiotics, opiates) in concentrated form.
Mobile infusion pump: are small device designed for ambulatory and home patients, used with chemotherapy, and opiate medications.
Implantable pumps: are infusion device surgically placed under the skin to provide continuous release of medication, typically an opiate. The reservoir in the pump is refilled by injecting the medication through a latex diaphragm in the pump.
Patient controlled analgesia pumps: used to administer narcotics intermittently or on demand.
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65. 453 PHT 65 Miniature Blood Pump Implanted in First Patient
Pumping up to 3 liters of blood per minute, this is a miniature implantable blood pump, the size of an AA battery. It is implanted superficially in a pocket, like a pacemaker. The device is intended to provide long-term, partial circulatory support in patients with chronic heart failure. The aim of the trial is to assess the safety of the device in patients with chronic heart failure who are waiting to receive heart transplants.
This isn't something you'd want to use on a long-term basis. The device is powered by a six pound battery pack worn on an external belt. It also needs to be recharged every 8-12 hours, so users need to keep a close eye on battery levels
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73. 453 PHT 73 If after a brief wait, you still have pain, press the button again to receive a second dose. It is common to press the button several times each hour to keep pain under control.
When Should I Use the PCA Pump?
When your pain is getting worse
A few minutes before you start something that can cause pain (such as turning, walking, or coughing and deep breathing).
Give yourself enough medicine to be comfortable. The medicine may not make you pain-free, but it should allow you to rest and move around.
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75. 453 PHT 75 Controllers
Unlike pumps, exert no pumping pressure on the IV fluid. Rather, they rely on gravity and control the infusion by counting drops electronically, or they infuse the fluid mechanically and electronically.
They are less complex and less expensive.
They have no moving components.
They are less sophisticated, but achieve reasonable accuracy.
They present difficulty with the administration of viscous solutions such as blood