PH-PHR 214 Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices LAB

PREPARATION no. 4 MAGNESIUM CITRATE ORAL
SOLUTION (MCOS)
• Official Title: Magnesium Citrate Oral Solution,
USP
• Category: Cathartic; Saline Cathartic
• Synonyms: Citrate, Citrate of Magnesia,
Trimagnesium Dicitrate, Citroma, Citronesia
• Uses: Magnesium Citrate is used as a laxative
used for constipation and bowel cleanses
before medical procedures such as
colonoscopy
• Official Definition: Magnesium Citrate oral
olution is a sterilized or pasteurized solution
containing, in each 100mL, not less than 7.59g of
anhydrous citric acid and an amount of
magensium citrate equivalent to not less than
1.55g and not more than 1.9g of magnesium
oxide (USP)
- Liquid preparations for oral use are often the
dosage form of choice for paediatric use.
- Liquid preparations for oral use may be supplied
as multidose or as single-dose preparations.
TYPES OF ORAL SOLUTIONS
- Syrup: sugar in water solution.
- Elixirs: hydroalcoholic solution.
- Tinctures: viscous solution used in treating cough.
- Spirits: solution of aromatic materials in alcohol.
- Oral Rehydration Solutions: an aqueous solution
composed of glucose and electrolytes.

INTRODUCTION
Category:
- Cathartic - Agents that are used to stimulate
evacuation of the bowels
- Mechanism of Action: INGREDIENTS: <Carboxylation & Oxidation>
- Mainly works through magnesium citrate’s - Magnesium Carbonate (Mg(CO3)4) 15g - laxative
ability to attract water through the tissues by a agent and cathartic; can be for acidity
process known as osmosis - Anhydrous Citric Acid 27.4g - reacts with
- It attracts enough water into the intestine to magnesium carbonate to form magnesium
induce defacation citrate; reacts with potassium bicarbonate to for
- quickens the evacuation of stool - saline carbonic acid;
cathartic; not absorbed by the GIT; Alters the - Syrup 60mL - adds sweetness
tonicity in your bowel - (from high conc to low - Talc 5g - used to remove impurities; dispersing
conc.) agent
- Lemon Oil 0.1mL - adds flavor
ORAL SOLUTIONS - Potassium Carbonate 2.5g - carbonates the
- Liquid preparations for oral administration solution to make it more pleasant to the patient
containing one or more active ingredients - Purified water. 350mL - solvent
dissolved in a suitable vehicle. COMPUTATION
- Contain flavorants and colorants to make them
more appealing to the patient;
- Contain stabilizers and antimicrobial
preservatives;
- Usually formulated such that a usual dose is
contained in a conveniently administered
volume but some have unusually large doses or
small doses

@mei_sria !1
PH-PHR 214 Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices LAB
PROCEDURE:
1. Dissolve 2.74g anhydrous Citric Acid in 15.00mL
of hot Purified water in a suitable dish
- Hot purified water is for killing old spores;
increase solubility
2. Mix 1.50g Magnesium Carbonate with 10.00mL
of Purified water and stir until it is dissolved
3. Slowly add the two mixtures, then add the Syrup,
heat the mixed liquids to the boiling point.
- To remove impurities or kill any pathogenic
microorganisms.
4. Titurate 0.01mL Lemoil oil with 0.5g talc
- Talc is used as clarifying agent which filters
out impurities. It also aids in adding the
volatile lemon oil (flavorant) to the aqueous
solution.
5. Mix the Citric Acid and Magnesium Carbonate
and Immediately add the lemon oil previously
triturated with Talc then filter the mixture, while
hot, into a strong bottle of suitable capacity.
6. Add boiled purified water to make the product
measure 35.00mL
7. Allow to cool, add the Potassium Bicarbonate,
then use Purified cotton as a stopper for the
bottle.
- More carbon dioxide will escape if it is hot.
- A stopper prevents carbon dioxide from
escaping
- prevents too much effevescece
8. Finally, shake the solution occasoinally until the
Potassium BIcarbonate is dissolved
9. Use a cork to seal the bottle, and sterilize or
pasteurize the solution
- to prevent bacterial or mold growth; air-tight
seal, to prevent effervescence - prevents
carbon gas from getting out; keeps
palatability
QUALITY CONTROL/PACKAGING
• Official title: Magnesium Citrate Oral Solution
• Appearance: Clear to yellow solution;
effervescent liquid
• Instability/IES: Unidentified floating objects, mold
formation, particle deposition
• Pourability: Easily poured
• pH: 5-9
@mei_sria
• Packaging and Storage: Preserve at controlled
room temp or in a cool place, in bottles
containing not less than 200mL; flint bottles; cork
• Labelling: For oral use only; Keep out of reach of
children
PREPARATION no. 5 SODIUM PHOSPHATES RECTAL
SOLUTION
• Official Title: Sodium Phosphates Rectal Solution,
USP
• Category: Saline Laxative
• Synonyms: Enema, Fleet Enema,
• Uses: relieves occasoinal constipation; causes
bowl movement; for surgery and endoscopy;
• Official Definition: Sodium Phosphates Rectal
Solution is a solution of Diabsic Sodium
PHosphate and Monobasic Sodium Phosphate,
or Dibasic Sodium Phosphate and Phosphoric
acid, in Purified Water. It contains in each
100mL, not less than 5.4g and not more than
6.6g of dibasic sodium phosphate, and not less
than 14.4g and not more than 17.6g of
monobasic sodium phosphate.
INTRODUCTION
- ENEMAS
- Larger - has a bag to hold liquid
- cleanses further into the large intestines
- DOUCHE AND IRRIGATIONS
- Smaller - has a bulb to hold liquid
- cleanses only the rectum
- aqueous solution, directly against a part or
cavity of the body.
- cleansing antiseptic agent
- can be for the eyes, pharyngeal - for
operation, nasal, and vaginal
- Irrigation - washes surgical incisions.
- has to be isotonic; sterile - pyrogen free
TYPES OF ENEMAS
- Cleansing/Evacuation Enema - water based;
meant to be held in the rectum for a short period
- Retention Enema - water or oil based; designed
to be held in the bowel for an extended period of
time ; has anthelmintic effect - for deworming ;
sedative effect and stimulating properties ;
employed to influence the general system.
!2
PH-PHR 214 Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices LAB
ADMINISTRATION OF ENEMAS
1. Fill enema bag with solution
2. Lubricate the end of tube
3. Lie on your left side and pull your knees to your
chest
4. Insert tube no more than 4 inches (10cm) into
the rectum
5. Deeply breathing, wait for the fluid to enter the
rectum until bag is empty
6. Remove nozzle from rectum
7. Carefully stand up and move to the toilet
INGREDIENTS
1. Monobasic Sodium Phosphate - 16g; acts as
cathartic / laxative- causes catharsis ; mixed to
produce a buffer system - to resist pH change
and to maintain optimal pH
2. Sodium Phosphate - 6g; the active ingredient;
for evacuation of bowel ; acts as saline laxative
and cathartic
3. Purified Water- 100mL a sufficient qtty to make;
acts as solvent
4. M Et Ft (mix to make) sodium Phosphates Rectal
Solution
COMPUTATIONS <ratio and proportion>
PROCEDURE
1. Dissolve 1.6g of monobasic sodium phosphate
and 0.6 sodium phosphate in 10mL hot or
lukewarm Purified water ; to avoid formation of
precipitates (white to colorless cyrstalline solids)
increases solubility of engredients
@mei_sria
PRECAUTIONS
1. Avoid interaction with other salts when making
the solution; ensures that the solution is pure
2. Do not use more than one enema in 24 hours
even if you have not had a bowel movement;
serious damage and side effects may occur
from excess dosage
*if patient has abdominal pain/vomitting, do not
use to prevent further complications due to its
acidic nature.
QUALITY CONTROL/PACKAGING
• Official title: Sodium Phosphates Rectal Solution,
USP
• Appearance: Clear, Colorless Liquid
• Instability/IES: Precipitation and discoloration;
needs to be pyrogen free
• Pourability: can be easily poured
• pH: 5.0-5.8 (1.5-6.5) acidic
• Sp.Gr.: 1.112 - 1.136
• Packaging and Storage: Preserve in tight, single-
unit containers; must be stored at a controlled
room temperature specifically 15-25 degrees C
• Labelling: for rectal use only
PREPARATION no. 6 SALINE NASAL MIST
Official Title: SALINE NASAL MIST (non-official); no
monograph. Unofficial - in the previous
pharmacopoeia, not in the current.
Category: Nasal Decongestant

Synonyms: Salt-water nasal solution

Uses: Restores moisture; relieves dry, crusted,
inflamed nasal membranes 

Official Definition of Saline Nasal Mist (SNM)-none 

Review of basic concepts
a. Sterile Solutions- Solutions that are absolutely
absent of viable microorganisms
b. Nasal Solutions – Usually aqueous solutions
designed to be administered into the nasal
passages in drops or sprays. It can also be
emulsions or suspensions. bufffered to maintin pH
5.5-6.5

Advantages:
!3
PH-PHR 214 Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices LAB
a. Rapid and efficient systemic absorption. CHARACTERISTICS OF AN IDEAL NASAL SPRAY
b. Avoids first-pass metabolism. One that is able to break up solutions into small
c. Highly vascularized, allowing for high 
 particles for spraying and absorption in the nasal
absorption. mucosa.
d. especially for preparations having intranasal
bioavailability comparable to injections INGREDIENTS AND COMPUTATIONS
- Sodium Chloride - makes the solution isotonic.
TERMINOLOGIES tonicity adjuster
- Inhalations- Drugs, solutions or 
 - Monobasic and Dibasic Potassium phosphate -
suspensions administered nasally or orally 
 Buffers the preparation; pH 5.5-6.5
for local or systemic effect. - Benzalkonium chlorid - antimicrobial used
- Inhalants- Drugs or combination of drugs 
 - Sterile water for injection - used solvent or diluent
that, because of their high vapor pressure,
can be carried by an air current in to the PROCEDURE
nasal passage where they give their effect ; 1. Dissolve the ingredients in sufficient sterile water
special class of inhalations. for injection to make 100mL of solution; for
- Inhaler- The container from where an inhalant aseptic preparation
is administered 2. Pass the solution through a 0.2um filter; for
- Atomizer- Devices that release medication in sterilization
the form of droplets. 1. A nasal product is for ONE PATIENT ONLY
- Vacuum Type - Depends of the suction 2. Avoid severely hypertonic solutions.
at the tip of the atomizer to release a
fine spray ASEPTIC PROCESSING - involves manufacturing
- Pressure Type - pressure in the can. dosage forms without Terminal sterilization. As such,
- Nebulizer- An apparatus that passes an each stage of the processing is kept sterile.
airstream over an inhalation preparation in
order to carry off small particles (ranging 0.5-5 MAINTENANCE OF STERILITY DURING PRODUCTION -
micrometers) for the patient to inhale. It brings Precautions and reasons for important steps
the medication deeper into the respiratory - Cleaning -> Compounding -> Filtration -> Filling ->
tract. Viable for diseases for larynx and Sealing -> Sterilization (Oxidation)
trachea and other disesases that inhibit
- Class 100 environment- A clean room with the
ventilation. max of 0 particles 5 um or larger in size per m3
and max of 3500 particles 0.5 um or larger in size
- Vaporizer An apparatus that releases a fine
mist of stream that may be used to humidify a per m3 of the room. ; search for class ABCD (EU
room classification)
- International Organization for Standardization
(ISO)

@mei_sria !4
PH-PHR 214 Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices LAB
- Laminar Air Flow Hood- A hood with air sweeping COMPUTATIONS
downward along parallel lines; ventilation
devices used within the lab to provide an aseptic
work area that helpls protect both the laboratory
personnel and the materials they are working
with.
- Horizontal - blows the air toward the personnel
as long as the preparation is not harmful.
- Vertical - up and down
- HEPA filter/ High Efficiency Particulate Air Filters-
Defined as filters 99.99% or more efficient in
removing from the air 0.3 um particles generated
by vaporisation of the hydrocarbon Emory 3004;
0.04g x 0.43 = 0.0172
Controls density particles that enter the clean
0.09g x 0.49 = 0.0441
room and is able to retain air particles greater
0.01g x 0.16 = 0.0016
than 0.3 micron in diameter.
0.9g NaCl - 0.0629g(hypotonic) = 0.08371 -> 0.84
- DOP - Dispersed oil Particulate
Packaging of sterile products, labeling and
- Disinfection- Decreasing the probability of storage requirement 

infection by destroying vegetative
Label- For nasal use only. keep out of reach of
microorganisms, but not ordinarily bacterial
children.

spores. Describe the use of chemical agents on
Packaging Req't- Preserve in tight containers,
inanimate objects.
must be done in sterile environment.
- Contamination- A process of making impure by
Packaging - Plastic spray bottles

the presence of microorganisms.
Container- 15 mL clean flint bottle, 

- Sterility- the state of being free of pathogenic
Storage- sterile, airtight, tamper-proof ; - Cool dry
organisms.
- Sterilization- the process of making something place, room temperature


free from bacteria or other living microorganisms

(including spores)

QUALITY CONTROL PARAMETERS


Appearance: Clear, colourless solution
pH: 5.5 - 6.5
Sterility - Absence of viable microorganims
Tonicity - 0.9-1.8% NaCl Solution 

Pourability- Easily pourable 

Instabilities- Discolouration or precipitation

@mei_sria !5