Bulk compounding is defined by the FDA as the combination, mixing or alteration of drug ingredients to create medications to fulfil the need of patient.

2. Bulk compounding is defined by the FDA as the combination,
mixing or alteration of drug ingredients to create medications to
fulfil the need of patient.
Need of bulk compounding-
Patients who cannot take commercially prepared formulations of a
drug.
Patient requiring limited dosage strength (very small dose for
infants).
Patient requiring different formulation such as turning pill/tablet
into liquid.

3. Patient requiring allergen free medication e.g. gluten.
Patients facing supply shortage of their normal drugs.
Children who want flavoured additives in liquid drugs.
Formulations that are compounded in hospital pharmacy
include:
Mixtures- Expectorant mixtures, antidirrhoeal mixtures, sodium
citrate mixture.
Syrups- Vasaka, codeine, & ipecacuanha syrup.
Solutions
Suspensions

4. Topical semisolids-
Ointments: Sulphur ointment, zinc oxide ointment.
Creams: Calamine cream, cetrimide cream.
Paints: Crystal violet compound paint.
Pastes: Zinc gelatin paste.
Gargles- Potassium permanganate gargle.
Lotions- Calamine lotion.
These formulations are compounded in hospitals in accordance
with the National Formulary of India (N.F.).
Labelling requirements & storage conditions should be observed
as per Drugs & Cosmetics Act & Rules.

5. Planning for Bulk compounding
Manufacturing
requirement
Material
requirement
Manufacturing
capacity
Manufacturing
sources
Manufacturing
staff
Operating cost
Quality control

6. Intravenous Admixture Services &
Incompatibilities
Intravenous admixtures
Intravenous admixtures are sterile
solutions prepared by mixing one or
more medications with intravenous fluid
& are administered via IV- administration
set directly to patient’s vein.
IV set

7. Following objectives expected to achieve by the
pharmacist
Preparation of final product under specific condition.
Rational choice of additive & mixing techniques for
avoiding drug interactions.
Appropriate labelling, dispensing & storage of final
product.

8. IV fluids commonly used for IV admixtures

9. Intravenous fluids are commonly used
for following clinical conditions:
• Correction of disturbances in electrolytes balance
• Correction of disturbances in body fluids
• For providing basic nutrition
• For providing total parenteral nutrition
• As a vehicle for other drug substances

10. Environment for IV admixture preparation
Laminar Air Flow
 Air is filtered through HEPA (High efficiency particulate air) filter.
 Air is moved with the velocity of 90 ft. per minute.
 Efficiency: 99.97%
 Removes particle larger than 0.3 µm.
 Inside of the hood is wiped down with a suitable disinfectant & allowed
to run for at least 30 min.
 Operator should wash hands thoroughly.
 For evaluating proper functioning of HEPA filters, the Dioctyl Phthalate
(DOP) test should be used.
 HEPA filters should be evaluated every 6 months.

11. Laminar Air Flow

12. Additives for IV Admixtures
Additives are injections packaged in ampoules or vials or sterile solids to
be reconstituted by adding suitable diluent before addition to IV fluid.
•A fresh sterile disposable syringe is used for each additive.
•Before withdrawing contents from ampoule, the ampoule is to be wiped
with disinfectant solution.
•In case of vials, the exposed area of rubber closure is to be disinfected.
•A sterile syringe is removed from its protective wrapping .
•The syringe needle is with its cover separated from syringe aseptically &
may be replaced with a sterile aspirating needle.
•Aspirating needle bear a stainless steel or nylon filter.

13. The filter removes glass particles & other particulates from the injection.
Then the aspirating needle is replaced with regular needle.
Now the injection is ready to be added into IV fluid to form IV admixture.
Regular needle
Aspirating needle

14. Wrong drug & dose errors (Due
to IV admixture left unlabelled)
Wrong diluent errors
Wrong rate of administration
errors
Errors in following aseptic
methods
Medication errors in IV drug preparation
& administration

15. Incompatible parenteral Admixtures
When one or more additives are combined with an IV fluid their
presence together may together modify the inherent characteristics of
the drug substance resulting in parenteral incompatibilities.
Incompatibilities
Physical incompatibility
Change in appearance,
change in color, pH
Chemical incompatibility
Chemical reactions
Therapeutic
incompatibility
Antagonistic effect
(opposite) effect

16. Pharmacist has to detect incompatibilities if more than one
parenteral product is prescribed for a patient.
The pharmacist should encourage use of few additives as possible in
IV fluids since the number of potential problems increases as the
number of additives increases.
Incompatibilities can be avoided by selecting another route of
administration for one or more of the drugs involved.

18. Definition: Total Parenteral Nutrition (TPN) is the
method of infusing nutrition to the patients
through Intravenous (IV) route. The nutrition is in
the form of fluids.
OR
Parenteral nutrition refers to feeding of
nutritional products to a person intravenously,
bypassing the usual process of eating and
digestion. When nutrition mix containing
glucose, salts, amino acids, lipids and vitamins is
administered to a person, it is called as total
parenteral nutrition.

19. Contents of TPN
TPN is mixture of separate
components which contain:
Carbohydrates,
Lipids (fat),
Amino acids,
Electrolytes,
Trace elements,
Vitamins and
Fluids.
TPN composition adjusted as per
requirement of individual
patient.

20. Carbohydrates: Carbohydrates is the main source of energy. Dextrose
and monohydrates of glucose used as primary source of carbohydrate in
TPN.
Lipids (Fat): Linoleic acid is used as primary source of essential fatty acid
in TPN.
Electrolytes:
Sodium (Na) - 100 to 200 mEq,
Potassium (K)- 80 to 120 mEq,
Magnesium (mg) - 8 to 16 mEq,
Calcium(Ca) - 5 to 10 mEq,
Chloride (C)- 100 to 200 mEq.
Vitamins:
Vitamins are required for the metabolism of carbohydrates, proteins,
fats. Water soluble (B1, B2,B3, B5, B6, B7, B9, B12 & C) & fat-soluble
vitamins (A, D, E & K) used in TPN formulation

21. 1. Gastrointestinal disorders-
Inflammatory Bowel disease (Inflammation of digestive tract),
Gastrointestinal ulcers, Small or large intestinal obstructions (Blockage of
small/large intestine), Intestinal Ischemia (Insufficient blood supply to
intestine due to blockage of blood vessels), Intestinal perforation (ruptured
bowel, a hole in the wall of part of the GI tract), Prolonged Diarrhea, Severe
pancreatitis, Paralytic ileus (Food isn’t moving properly), Crohn’s disease
(ulcer on the mucous membrane of the mouth).
2. Cancer patients on Chemotherapy
3. Geriatric population-
Cardiac, renal impairments, insulin resistance, vitamin deficiencies.
4. Conditions like accident and surgery

22. Most common complications-
Hypophosphatemia, hypokalemia, hyperglycemia, hypercapnia/
hypercarbia (too much carbon dioxide (CO 2) in bloodstream), decreased
GI motility.
Possible complications-
Infection:
Infection due to catheter. May lead to death due to septic shock (Severe
drop in B.P).
Catheter complications include pneumothorax (air leaks into the space
between your lung and chest wall), accidental arterial puncture, catheter
related sepsis (body's response to infection causes injury to its own
tissues and organs).

23. Blood Clots:
Chronic IV access leaves a foreign body in vascular system &
blood clot on this IV line are common. Such clot upon breaking
if travels to lungs may lead to pulmonary embolism & death.
Fatty liver/ Liver failure:
Linoleic acid (omega-6-fatty acid) is responsible for liver
disorders.
Hunger:
In TPN the taste, smell & physical fullness of stomach
requirements are not fulfilled & so the patient experiences the
hunger.

24. Cholecystitis (inflammation of the gallbladder, flow of bile
from the liver to the duodenum is impaired.):
Due to complete disuse of GIT, there may be cholecystitis &
other hepatobiliary dysfunctions such as steatosis (fat in liver),
steatohepatitis (advanced stage of fatty liver)
Hypersensitivity:
Hypersensitivity reactions may occur.
Rare.
Medication incompatibility

25. Substance Normal patient High stress Fluid- restricted
Amino acids 85 g 128 g 75 g
Dextrose 250 g 350 g 250 g
Lipids 100 g 100 g 50 g
Na+ 150 mEq 155 mEq 80 mEq
K+ 80 mEq 80 mEq 40 mEq
Ca++ 360 mg 360 mg 180 mg
Mg++ 240 mg 240 mg 120 mg
Acetate 72 mEq 226 mEq 134 mg
Cl- 143 mEq 145 mEq 70 mEq
P 310 mg 465 mg 233 mEq
MVI-12 10 mL 10 mL 10 mL
Trace elements 5 mL 5 mL 5 mL