1. LARGE VOLUME Parenterals

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala8
STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala

9. STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala9
STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala

10. 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

11. Extracellular and Intracellular Fluids
Figure 27.3
STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. Nutritional Requirements
Amino acids
Glucose
Lipid
Minerals
Vitamins
Water and electrolytes
Trace elements
STES,Sinhgad Institute of Pharmaceutical Sciences, Lonavala

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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

46. 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