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LARGE VOLUME Parenterals
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Classification Of Parenterals
Based on Volume: 1. Small Volume Parenterals(SVP), 2. Large Volume Parenterals(LVP). Based On State Of Product According to USP (SVP) 1. Solution Or Emulsion of medicament, 2. Dry Solids or Liq. Concentrate without additives, 3. Dry Solids or Liq. Concentrate with additives, 4. Suspension of solids not for IV or Intra Spinal use, 5. Dry solids on reconstitution become suspension STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Small Volume Parenterals
USP Defn: An Injection that is packed in containers labeled as containing 100 mL or less Components of SVP Vehicle: Sr. No. Type Example 1. Aqueous Purified Water,WFI,Sterile WFI,etc 2. Water Miscible PEG, Glycerin, etc 3. Non-Aqueous Vegetable Oils 4. Synthetic Ethyl oleate, Isopropyl Myristate STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Component Example Usual Conc. 2.Antimicrobial Preservative Benzalkonium Cl, Benzyl Alcohol, etc. 0.01% 1-2% 3. Antioxidants Water soluble : Sulfurous & Ascorbic a. Thiol derivative Water Insoluble: Propyl Gallate BHT & BHA % 0.1% 4. Buffers Acetate Buffer & Citrate Buffer Phosphate Buffer Glutamate Buffer pH 3-6 pH 6-8 pH 8-10 5.Tonicity Adjusting Electrolyte : NaCl Non-Electrolyte : Dextrose % 4-5 % 6.Surfactant Poly-oxy ethylene : Tween & Pluoronic Sorbitan mono oleate : Spans % % 7.Chelating A. Di Sod. EDTA % 8. Bulking agents Lactose Mannitol & Sorbitol 1-8% 1-10% STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Large Volume Parenterals
Defn: LVP are Parenterals designed to provide -Fluid(water), Calories(Dextrose soln), -Electrolytes(Saline soln), or -Combination of these. Volume mL IV infusion technique is “Venoclysis”. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Requirements for LVP Sterile, Non Pyrogenic, Free from Particulate matter Volume mL, Single dose unit, No Preservative, Clear solution except Fat Emulsion, Isotonic, but Hypertonic also administered in TPN. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Body Fluid Compartments
2/3 (65%) of TBW is intracellular (ICF) 1/3 extracellular water 25 % interstitial fluid (ISF) 5- 8 % in plasma (IVF intravascular fluid) 1- 2 % in transcellular fluids – CSF, intraocular fluids, serous membranes, and in GI, respiratory and urinary tracts (third space) 7 STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Major Compartments for Fluids
INTRACELLULAR FLUID (ICF) Inside cell Most of body fluid here - 63%-65% weight Decreased in elderly EXTRACELLULAR FLUID (ECF) Outside cell Intravascular fluid - within blood vessels (5%) Interstitial fluid - between cells & blood vessels (15-25%) Transcellular fluid - cerebrospinal, pericardial , synovial STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Extracellular and Intracellular Fluids
Figure 27.3 STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Cations in Body Fluids Major cations inside the cell (ICF) include Sodium (Na) Potassium (K) Magnesium (Mg) Major cations outside the cell (ECF) include Calcisum (Ca) The concentration of cations inside the cell and outside the cell differs as shown in figure on the right e.g. there is much higher concentration of potassium in the ICF than in the ECF, there is much higher concentration of sodium in the ECF than in the ICF. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Anions in Body Fluids Major Anions inside the cell (ICF) include Chloride (Cl) Proteins Phosphates (HPO4) Bicarbonate (HCO3) SO4 Major Anions outside the cell (ECF) include The concentration of anions inside the cell and outside the cell differs as shown in figure on the right e.g. there is much higher concentration of proteins and Phosphate in the ICF than in the ECF, there is much higher concentration of chloride in the ECF than in the ICF. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Examples: Dextrose injection IP : available in 2 , 5 , 10 , 25 & 50 % w/v solution. Used for Fluids replinisher, To provide nutrition Sodium chloride & Dextrose injection IP: (DNS) Contains 0.11 to 0.9 % Sodium chloride 2.5 to 5.0 % Dextrose Electrolyte replinisher Nutrient replinisher STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Sodium chloride injection IP: 0.9 % conc. Also known as normal saline solution Used as Isotonic vehicle Fluids replenisher, Electrolyte replenisher Sodium lactate injection IP: Contains 1.75 to 1.95 % w/v of sodium lactate STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Mannitol injection IP: Contains 5, 10 , 15, 20 % of mannitol Used as : Diagnostic aid Renal function determination As a diuretic Mannitol & Sodium chloride injection IP: Contains 5, 10 , 15, 20 % of mannitol & 0.45 % of Sodium chloride STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Other solutions: Ringer injection IP Ringer lactate solution for injection IP Common uses : Used in surgery patients In replacement therapy Providing basic nutrition For providing TPN As a vehicle for other drug subs. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Types of Large Volume Parenterals
Types Of LVP 1.Hyper alimentation Solutions, 2.Cardiolpagic Solutions, 3.Peritoneal Dialysis Solution, 4.Irrigating Solutions. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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1.Hyperalimentation Solution
Adm. Of large amt. of nutrients to patients who unable to take food orally, at caloric intake of 4000 kCal/day. Subclavian vein cannulation : Infusion of Hypertonic soln. Formulation : mix. Of Dextrose, Amino acids, Lipids, Electrolytes, & Vitamins. Use: 1.Adm. of Life saving/sustaining drug to Comatose patient. 2.Patient undergoing t/t of GI disease STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Total Parenterals Nutrition
Modified term for Hyperalimentation Defn: IV adm. Of Caloric, Nitrogen, & other nutrients in sufficient qt. to achieve tissue synthesis & anabolism Content Sources 1.Calories Dextrose, 2.Nitorgen Crystalline amino Acids 3.Electolyte Na, K, Mg, Cl, Po4 5.Vitamin Water soluble & Fat soluble 6.Elements Traces of Zn, Cu, Mn, Cr STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Indication For Use of TPN
GI disease, Major trauma, Septicemia, Major Abdominal Surgery, Malignancy of Small Bowel, Radiation Enteritis, Chemotherapy & Radiotherapy, Bone Marrow Transplantation, Prolonged Coma. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Total Parenteral Nutrition
TPN stands for Total Parenteral Nutrition. This is a complete form of nutrition, containing protein, sugar, fat and added vitamins and minerals as needed for each individual. Total Parenteral Nutrition (TPN) may be defined as provision of nutrition for metabolic requirements and growth through the parenteral route. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Total Parenteral Nutrition (TPN) (Intravenous Nutrition)
TPN refers to the provision of all required nutrients, exclusively by the Intravenous route. Parenteral Nutrition (PN)can be used to supplement ordinary or tube feeding. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Components of TPN solutions: (1) Protein as crystalline amino acids. (2) Fats as lipids. (3) Carbohydrate as glucose. (4) Electrolytes–Sodium, potassium, chloride, calcium and magnesium. (5) Metals/Trace elements–Zinc, copper, manganese, chromium, selenium. (6) Vitamins A, C, D, E, K, thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, choline and folic acid. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Why it is necessary? TPN might be necessary if: a patient is severely undernourished, and needs to have surgery, radiotherapy or chemotherapy; a patient suffers from chronic diarrhea and vomiting; a baby's gut is too immature; a patient's (their "gastrointestinal tract") is paralysed, for example after major surgery. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Normal Diet TPN Protein…………Amino Acids Carbohydrates…Dextrose Fat……………..Lipid Emulsion Vitamins………Multivitamin Infusion Minerals………Electrolytes & Trace Elements STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Nutritional Requirements
Amino acids Glucose Lipid Minerals Vitamins Water and electrolytes Trace elements STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Total Parenteral Nutrition Electrolytes
Daily Requirement Standard Concentration Na meq 35-50 meq/L K meq 30-40 meq/L Ca 3-30 meq 5 meq/L Mg 10-45 meq 5-10 meq/L Phos. 30-50 mM 12-15 mM/L STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
When is it necessary? TPN is normally used following surgery, when feeding by mouth or using the gut is not possible, When a person's digestive system cannot absorb nutrients due to chronic disease, or, alternatively, if a person's nutrient requirement cannot be met by enteral feeding (tube feeding) and supplementation. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Short-term TPN may be used if a person's digestive system has shut down (for instance by Peritonitis), and they are at a low enough weight to cause concerns about nutrition during an extended hospital stay. Long-term TPN is occasionally used to treat people suffering the extended consequences of an accident or surgery. Most controversially, TPN has extended the life of a small number of children born with nonexistent or severely birth-deformed guts. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Indications for TPN Short-term use Bowel injury /surgery Bowel disease Severe malnutrition Nutritional preparation prior to surgery. Malabsorption - bowel cancer Long-term use Prolonged Intestinal Failure Crohn’s Disease Bowel resection STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
The preferred method of delivering TPN is with a medical infusion pump. A sterile bag of nutrient solution, between 500 mL and 4 L is provided. The pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
The nutrient solution consists of water, glucose, salts, amino acids, vitamins and (more controversially) sometimes emulsified fats. Long term TPN patients sometimes suffer from lack of trace nutrients or electrolyte imbalances. Because increased blood sugar commonly occurs with TPN, insulin may also be added to the infusion. Occasionally, other drugs are added as well, sometimes unnecessarily. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Complications of TPN Sepsis Air embolism Clotted catheter line Catheter displacement Fluid overload Hyperglycaemia Rebound Hypoglycaemia STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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2. Cardioplegic Solutions
Are LVP used in Heart surgery to prevent injury to myocardium during reperfusion, as well as to maintain bloodless operating field. Maintains the Diastolic arrest. Adm. In cold form. Slightly alkaline to compensate Metabolic acidosis, Hypertonic Use: To minimize reperfusion injury resulting from tissue edema STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
3. Dialysis Solution Infused continuously into abdominal cavity, bathing peritoneum & are then continuously withdrawn. Formulation:- Glucose , - Antibiotics as Prophylactic Use: Removal of toxic substances from body. To aid & accelerate excretion normal. To treat acute renal insufficiency STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
General uses : Renal failure waste product is removed Maintain electrolytes Also called as haemodialysis or intraperitoneal dialysis Transplantation of kidney Poisoning cases STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Haemodialysis: To remove toxins from blood In haemodialysis, the blood from artery is passed thr’ artificial dialysis membrane, bathed in dialysis fluid. The dialysis membrane is permeable to urea, electrolytes & dextrose but not to plasma proteins & lipids So excess of urea is passed out from blood thr’ dialysis fluid. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
After dialysis blood is returned back to the body circulation thr’ vein. A kidney unit may require more than 1200 litres of solution / week. So haemodialysis fluid is prepared in conc. Form then it is diluted with deionised water or dist. water before use. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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COMPOSITION Dextrose monohydrate ----------- 8.0 gm
Composition of Concentrated Haemodialysis Fluid BPC Dilute 1 liter of conc. solution with 39 liters of water to make 40 litres. Storage: store in warm place as it is liable to convert into crystals on storage. Dextrose monohydrate Sodium acetate Lactic acid Sodium chloride Potassium chloride Freshly boiled & cooled water -q.s. 8.0 gm 19.04 gm 0.4 ml 22.24 gm 0.4 gm 100 ml STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Intraperitoneal Dialysis: Peritoneal cavity is irrigated with dialysis fluid. Peritoneum acts as a semi permeable membrane Toxic subs. excreted by kidney are removed. Requirements: Sterile Pyrogen free STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Composition of Fluid Intraperitoneal Dialysis IP 1985
Sterilize by autoclave immediately after preparation. Sodium chloride Sodium acetate Calcium chloride Magnesium chloride Sodium metabisulphite Dextrose (anhydrous) Purified water q.s.----- 5.56 gm 4.76 gm 0.22 gm 0.152 gm 0.15 gm 17.30 gm 1000 ml STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
4.Irrigating solutions To irrigate, flush & aid in cleansing body cavities & wounds. Certain IV soln(Normal Saline) may be used as irrigating soln, but soln designed as Irrigating soln should not be used Paretentrally. Use: treatment of serious wounds infused into blood stream. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES, Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Examples Of LVP fluids Sr. No LVP Common Name Conc. % Therapeutic Use 1. Dextrose Inj Glucose 5,10, 20,50, Fluid & Caloric Supplement 2. NaCl Inj. Normal Saline Soln 0.9, 3.5 Fluid & Electrolyte Supplement 3. Ringers Soln Nacl KCl CaCl 4. Lactate Ringer Inj. Hartmann’s Nacl-0.6, KCl-0.03 CaCl Na.Lactate -0.3 Systemic Alkaliser, Fluid & Electrolyte Replishner 5. Mannitol Inj. _ 5, 10, 15, 20. Osmotic Diuresis 6. IV fat emulsion 10, 15, 20 Caloric STES, Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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Difference Between SVP & LVP
PARAMETER SVP LVP Volume 100 mL or Less mL Routs IV, IM, & SC IV-LVP & Non-IV-LVP Dosage Unit Single or Multiple( USP=max. size 30mL) Single Technique Vein Puncture Venoclysis Needle 1½″, Gauge 1½″, Gauge Preservative Used Not Used Buffers Formulations Soln, Emulsion, Suspension. Soln, & o/w Nutrient Emulsion STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Continued.. PARAMETER SVP LVP Use As Therapeutic agent, As Diagnostic agent, As Nutrition, In Detoxification, Aid during surgery. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala
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