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PRACTICE SCHOOL REPORT

On

PHARMACEUTICS (BP 706PS)

Submitted in Partial Fulfilment of the Requirements for the Degree of Bachelor

of Pharmacy

By

Gurnoor
B. Pharm 7th sem, 2023
(Registration no. 40320000047)g
University Institute of Pharmaceutical Sciences
Panjab University, Chandigarh

Subject expert:
Dr. Amita Sarwal
(University Institute of Pharmaceutical Sciences)

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TABLE OF CONTENTS

S.NO. AIM INSTRUCTOR PAGE

NO.

1 To prepare Aspirin Chewable Tablets by Dr. Amita Sarwal 3-4

dry granulation technique and perform its
evaluation.

2 To prepare and submit 2ml ampoules of Dr. Amita Sarwal 5-6

Phenol Oil Injection. B.P.

3 To prepare and submit ampoules of ascorbic Dr. Amita Sarwal 7-9

acid injection.

4 To study about the detailed Evaluation of Dr. Amita Sarwal 10-16

Tablets

5 Dr.Ranjana Bhandari 17-23

To predict the concentration of drug after
intravenous administration following one
CBM kinetics from given data.

6 To simulate serum level profile of a drug Dr.Ranjana Bhandari 24-28

obeying 1-CBM when administered via IV
infusion.

7. To simulate serum level profile of a drug Dr.Ranjana Bhandari 29-31

obeying 1-CBM when administered via IV
infusion.

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EXERCISE 1
Aim: To prepare Aspirin Chewable Tablets by dry granulation technique and perform its evaluation.
Reference:
Aulton’s Pharmaceutics- The design and manufacture of medicines; 5th edition; Published by Churchill
Livingstone Elsevier; Page -456
United States Pharmacopoeia (2007). The US Pharmacopoeial Convention. 35th edn. Inc.12601 Twinbrook
Parkway, Rockville MD20852.
Working Formula:
INGREDIENTS QUANTITY
Aspirin 75 mg
Mannitol-lactose granulation 400 mg
Glycine 10 mg
Saccharin 0.3 mg
Flavour 3.5 mg
Colour q.s
Stearic acid 10 mg
Talc 21.5 mg

Theory:
Chewable tablets are those that can be broken up in the mouth before being swallowed. The chewable dosage
forms market, which is led by chewy squares and chewing gums, is significantly smaller than the overall
market. When chewed, chewable pills leave a pleasant-tasting residue in the oral cavity that is not bitter or
disagreeable to swallow.
Chewable tablets are designed in such a way that they can be crushed simply by chewing. They are frequently
made for those who have difficulty swallowing medicines. These patient categories may include infants and
young children who have not yet mastered the skill of swallowing medications with fluids, as well as
individuals with pathologically damaged throats.
The pill breaks down into smaller pieces as soon as chewing starts, and this breakdown and subsequent
absorption occur to deliver the right pharmacologic action. Chewable tablets offer a significant benefit over
conventional solid tablets or capsules: their greater bioavailability results from their accelerated absorption into
the gastrointestinal system following dissolution or chewing in the mouth. This is due to the fact that they enter
the digestive system as granules or solutions.
Dry granulation uses pressure to turn primary powder particles into granules without the need for a liquid in
between. Thus, it stays away from heat-temperature combinations that could cause the product to deteriorate.
Significance of ingredients :

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Acetylsalicylic acid, or ASA, is known as ASPIRIN. It is prescribed to treat a number of illnesses, including
the common cold, influenza, low back and neck pain, dysmenorrhea, headaches, toothaches, sprains and
strains, fractures, myositis, neuralgia, arthritis, bursitis, burns, and pain following dental and surgical
procedures.
An artificial sweetener is SODIUM SACCHARIN. Approximately 550 times sweeter than sucrose is sodium
saccharin. Because only a small amount of sodium saccharin can deliver the right level of sweetness, it is used
to minimize tablet weight. It is non-toxic and goes out of the body in a day without changing.
A polyol, or sugar alcohol, MANNITOL is a sorbitol isomer. Pharmaceutical products use mannitol (C6H8
(OH) 6) as an excipient for chewable tablets and as a sweetener. About half as sweet as sucrose, mannitol is
produced industrially from the sugar fructose. Since mannitol has a cooling effect, harsh flavors are frequently
covered up by it.
LACTOSE: Only the milk produced by mammals contains lactose, a naturally occurring simple carbohydrate,
sometimes known as sugar. Because of this, it is also frequently called "milk sugar." A common filler or filler-
binder in the production of medicine tablets and capsules is lactose.
GLYCINE serves as both a sweetener and lubricant. Gastric inflammation is lessened by glycine.
This formulation uses Stearic Acid as a glidant.
SPRAY DRIED ORANGE FLAVOR is a flavoring ingredient that improves tablet palatability.

Vibrant A colorant called orange lake color is employed.

Procedure:
 Mannitol lactose granulation- take (2parts) mannitol, (1part) lactose, orange lake color (q.s.), gelatin
solution (5% aqueous) to granulate.
 Mannitol lactose granulation done to avoid direct exposure of moisture to aspirin.
 Pass this dough through mentioned sieve to form granules and dry them in oven. Pass aspirin through
appropriate sieve.
 Mix aspirin, granules and rest of ingredients and blend them together.
 Used the obtained mixture to compress tablets in rotary tablet press machine.
Uses:
It relieves pain and fever and is used to treat rheumatic fever.
It is used to protect heart stents and bypass grafts,
treat certain forms of arthritis, and reduce the risk of heart attacks, strokes, and mortality in certain individuals.

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EXERCISE 2
Aim: To prepare and submit 2ml ampoules of Phenol Oil Injection. B.P.

Reference:
British Pharmaceutical Codex Pg. No. 1121
Phenol preparations. (2016). In British pharmacopoeia (page no. 1000).

Working Formula:

INGREDIENTS QUANTITY
Phenol 5g
Arachis Oil q.s to 100 ml

Theory:
• One treatment option for chronic hemorrhoids, a condition that many individuals have, is
sclerotherapy. Sclerotherapy involves injecting phenol into the hemorrhoidal submucosa.

• The symptoms and indicators of an overdose of oily phenol injection include stomach pain or
discomfort, elevated blood methemoglobin levels, fainting, hemoglobin in the urine, blue lips or skin,
and irregular pulse.

• Phenol is a sclerosing (hardening) agent with analgesic properties. Adults, including seniors, can
receive injections of oily phenol to treat piles (internal hemorrhoids). A small amount of oily phenol
(between 2 and 3 ml) will be made at the bottom of the pile, and a maximum total dosage of 10 ml may
be injected into multiple locations at once. Children and babies should not receive this medication.
• Necrotizing fasciitis, a dangerous infection that spreads quickly through the deeper layers of the skin;
signs of retroperitoneal sepsis, a dangerous infection that causes fever, chills, nausea, or general
malaise; skin rashes or lumps; itching, redness, or swelling in the affected area; hepatitis, an
inflammation of the liver; yellowing of the skin; general malaise; and loss of appetite.

Storage of phenol oily injection:

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 Keep out of the sight and reach of children.

 This product has an expiry date on the ampoule labels, vial labels and carton labels.

 You should not be given Oily Phenol Injection after the expiry date (EXP) which is stated on the outer
packaging.

Shelf life

3 years (36 month) when packaged in glass ampoules

Procedure:

 Weigh phenol on watch glass without touching and required amount of oil in a beaker.

 Mix, and keep on water bath.

 After heating, it becomes clear solution

.
 This solution was filled in previously dried amber colored ampules (2ml). 2-2.5 ml of solution was
added to compensate for the material that sticks to the ampule during administration

Uses:
 Phenol is a hardening (sclerosing) agent with pain killing properties.

 Oily phenol injection is used in the treatment of piles (internal haemorrhoids).

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EXERCISE 3
Aim: To prepare and submit ampoules of ascorbic acid injection.

Reference:
Gunn, C., Cooper, J. W., & Carter, S. J. (2008). The Formulations of Injections. In Cooper and Gunn's
dispensing for pharmaceutical students New Delhi: CBS; pp. 269,317-320.
Theory:
• Vitamin C, or ascorbic acid, is a water-soluble vitamin. It appears as a powder or crystal that is white
or slightly yellow with a little acidic flavor. This product is antiscorbutic.Light exposure causes it to
progressively darken. It oxidizes quickly in solution, but in the dry state, it is fairly stable in air.
Ascorbic acid, also known as vitamin C, is insoluble in benzene, ether, and chloroform but freely
soluble in water and only sporadically soluble in alcohol.L-ascorbic acid is the molecular term for
ascorbic acid, or vitamin C. C6H806 is the empirical formula, while 176.13 is the molecular weight.

• This is the arrangement:

• The injection of ascorbic acid (vitamin C) is a sterile solution. Ascorbic Acid (vitamin C) 250 mg and
Edetate Disodium 0.025% in Water for Injection qs are contained in each milliliter. prepared with the
help of baking soda. The pH may have been adjusted using hydrochloric acid or sodium hydroxide.

Dosage and administration:

• Oral administration of ascorbic acid (vitamin C) is the conventional method. If subcutaneous,
intravenous, or IM administration of the medicine is not possible or if malabsorption is suspected,
several routes of delivery can be used. It has been found that the optimal parenteral route for vitamin
supplementation is via intramuscular injection (IM).
• To reduce the negative effects of intravenous administration, diluting the drug with a large volume
parenteral solution, such as glucose, normal saline, or water for injection, is advised.

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• Adults should take 70–150 mg of vitamin C per day on average to be protected. Doses ranging from
300 mg to 1 g daily are advised in cases of scurvy. Nonetheless, normal persons have received
parenteral doses of up to 6 g without exhibiting any signs of toxicity. Working formula:
INGREDIENTS QUANTITY
Ascorbic acid 25 g
Sodium Carbonate 4.58 g
p-chloro meta cresol 0.1g
Water for injection q. 100 ml
➢ Sterilisation: The sealed ampoules are sterilised by steaming for 30 minutes.
➢ Storage: Store in a cool and dark place not exceeding temperature of 25°C.
➢ Synonyms: Vitamin C injection, L-ascorbic acid injection.

Procedure:

 2/3rd of the total volume of water is placed in the beaker.

 Ascorbic acid is weighed and suspended in water with continuous stirring.
 Sodium bicarbonate is slowly added with vigorous stirring. Effervescence is produced.
 After subsiding the effervescence, remaining sodium bicarbonate is added. The process is
continued till ascorbic acid dissolves completely.
 Para chloro meta cresol is added and stirred to dissolve.
 The pH is adjusted to 5.7.
 The solution is filtered through G-4 filter

Uses:

 Used to treat vitamin C deficiency

 Used to treat Scurvy
 Enhance absorption of Iron

Evaluation test of tablets

1. weight variation test u.s.p.
 Take 20 tablets and weigh individually.
 Calculate the average tablet weight and compare it to the individual tablet weight. A tablet
passes the u.s.p. test if no more than two tablets are outside the % limit and the difference
between them is greater than twice the percentage limit.

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S.No Average weight USP Average weight IP/BP % difference

allowed

1. 130mg or less 80mg or less 10 10

2. More than 130mg less More than 80mg less than 250 7.5
mg
than 324 mg

3. More than 324mg less More than 250mg 5

2. Hardness test and friability test:

 Tablets must have a specific level of strength or hardness as well as resistance to friability in
order to endure mechanical shaking during manufacturing, packaging, and delivery. The
strength of crushing a tablet is measured by its hardness.
 Monsanto testers, Pfizer testers, and Erweka testers are examples of hardness testers.
 The Roche friabilator is an example of a friability tester.
3. Organoleptic Evaluation
This involves the evaluation of properties such as color, odor and taste of tablet based on their
appearance.
4. Disintegration test and dissolution test
The process through which solid oral dosages, like tablets, break down into smaller particles or
granules is known as disintegration. The process by which a substance dissolves into a solution is
known as dissolution. The bioavailability and bioequivalence study is linked to the USP dissolving test
in the monograph.
All the excipients used in the preparation of Aspirin tablet are water-soluble because they promote
salivation by stimulating salivary secretions which makes these tablets to be easily swallowed

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EXERCISE 4
AIM 4 To study about the detailed Evaluation of Tablets
THEORY
During the compression of tablets, in-process tests are routinely run to monitor the process including
tests for tablet weight, weight variation, hardness, thickness, disintegration and various evaulations
of elegance. The inprocess tests are performed by production and/or quality control (QC) personnel.
To design tablets and later monitor tablet production quality, quantitative evaluations and
assessments of a tablet’s chemical, physical, and bioavailability properties must be made.
General Appearance
The control of the general appearance of a tablet involves the measurement of a number of attributes
such as a tablet’s size, shape, color, presence or absence of an odor, taste, surface texture, physical
flaws and consistency, and legibility of any identifying markings.
Size and Shape
A compressed tablet’s shape and dimensions are determined by the tooling during the compression
process. The thickness of a tablet is the only dimensional variable related to the process. At a
constant compressive load, tablet thickness varies with changes in die fill, with particle size
distribution and packing of the particle mix being compressed, and with tablet weight, while with a
constant die fill, thickness varies with variations in compressive load. Tablet thickness is consistent
batch to batch or within a batch only if the tablet granulation or powder blend is adequately
consistent in particle size and size distribution, if the punch tooling is of consistent length, and if the
tablet press is clean and in good working order. Tablet thickness should be controlled within a ±5%
variation of a standard value.
Unique Identification Markings
The type of informational markings placed on a tablet usually includes the company name or
symbol, a product code such as that from the National Drug Code (NDC) number, the product name,
or the product potency
Organoleptic Properties
COLOUR: The colour of a product must be uniform within a single tablet, from tablet to tablet, and
from lot to lot. Nonuniformity of colouring not only lacks aesthetic appeal but could be associated by
the consumer with nonuniformity of content and general poor quality of the product.
ODOUR: The presence of an odour in a batch of tablets could indicate a stability problem, such as
the characteristic odour of acetic acid in degrading aspirin tablets; however, the presence of an
odour could be characteristic of the drug, (vitamins have a characteristic odour)
TASTE: Taste is important in consumer acceptance of chewable tablets. Many companies utilize
taste panels to judge the preference of different flavours and flavour levels in the development of a
product
Hardness

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Tablets require a certain amount of strength, or hardness and resistance to friability, to withstand
mechanical shocks of handling in manufacture, packaging, and shipping. In addition, tablets should
be able to withstand reasonable abuse when in the hands of the consumer, such as bouncing about
in a woman’s purse in a partially filled prescription bottle. Adequate tablet hardness and resistance
to powdering and friability are necessary requisites for consumer acceptance
Several devices operating in this manner have been and continue to be used to test tablet hardness:
the Monsanto tester, the Strong-Cobb tester, the Pfizer tester, the Erweka tester, and the Schleuniger
tester.
The Pfizer tester was developed and made available to the
industry.This tester operates on the same mechanical principle as a
pair of pliers. As the plier’s handles are squeezed, the tablet is
compressed between a holding anvil and a piston connected to a
direct force reading gauge. The dial indicator remains at the
reading where the tablet breaks and is returned to zero by
depressing a reset button. The Pfizer tester became extensively
used in comparison to the earlier testers, based on its simplicity,
low cost, and the rapidity with which it could be used.

Fig: Pfizer Hardness Tester

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Friability
The friability test is official in USP but not in BP and IP The laboratory friability tester is known as
the Roche friabilator. This device, shown in Fig. 13.13, subjects a number of tablets to the combined
effects of abrasion and shock by utilizing a transparent synthetic polymer chamber with an internal
diameter between 283 and 291 mm and a depth between 36 and 40 mm that revolves at 25 ±1 rpm.
The tablets are tumbled from a distance of six inches at each turn of the drum by a curved projection.
Normally, a preweighed tablet sample is placed in the friabilator (w), which is then operated for 100
revolutions. For tablets with a unit weight equal to or less than 650 mg, take a sample of whole tablets
corresponding as near as possible to 6.5 g. For tablets with a unit weight of more than 650 mg, take a
sample of 10 whole tablets. After testing, the tablets are dusted and reweighed (w0 ). The friability, f,
is given by:

𝜔−𝜔0
𝐹 = 100( ) Fig: Roche Friability Apparatus

Weight Variation
With a tablet designed to contain a specific amount of drug in a specific amount of tablet formula,
the weight of the tablet being made is routinely measured to help ensure that a tablet contains the
proper amount of drug. The weight variation test is run by weighing 10 tablets individually,

calculating the average weight, and comparing the individual tablet weights to the average. The
requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less
than or equal to 15%. If the acceptance value is greater than 15%, test the next 20 units and calculate
the acceptance value. The requirements are met if the final acceptance value of the 30 dosage units is
less than or equal to 15%, and no individual content of any dosage unit is less than nor more than
25%. The weight variation test would be a satisfactory method of determining the drug content
uniformity of tablets
IP/BP LIMIT USP

80 mg or less ± 10% 130 mg or less

>80 mg and <250 mg ± 7.5% >130 mg and <324 mg

250 mg or more ± 5% 324 mg or more

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Content Uniformity
To assure uniform potency for tablets of low-dose drugs, a content uniformity test is applied. In this
test, 30 tablets are randomly selected for the sample, and at least 10 of them are assayed individually.
Nine of the 10 tablets must contain not less than 85% or more than 115% of the labeled drug content.
The tenth tablet may not contain less than 75% or more than 125% of the labeled content. If these
conditions are not met, the tablets remaining from the 30 must be assayed individually, and none
may fall outside of the 85 to 115% range. In evaluating a particular lot of tablets, several samples of
tablets should be taken from various parts of the production run to satisfy statistical procedures.
Disintegration
The USP device to test disintegration uses 6 glass tubes that are 3 inches long, open at the top, and
held against a 10-mesh screen at the bottom end of the basket rack assembly (Fig. 13.14). To test for
disintegration time, one tablet is placed in each tube, and the basket rack is positioned in a 1-L
beaker of water, simulated gastric fluid, or simulated intestinal fluid, at 37°C ± 2°C, such that the
tablets remain 2.5 cm below the surface of the liquid on their upward movement and descend not
closer than 2.5 cm from the bottom of the beaker. A standard motor-driven device is used to move
the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a
frequency of 28 to 32 cycles per minute. Perforated plastic discs may also be used in the test. These
are placed on top of the tablets and impart an abrasive action to the tablets. The discs may or may not
be meaningful or impart more sensitivity to the test, but they are useful for tablets that float

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To be in compliance with the USP standards, the tablets

must disintegrate, and all particles must pass through the
10-mesh screen in the time specified. If any residue
remains, it must have a soft mass with no palpably firm
core.
Uncoated USP tablets have disintegration time standards as
low as 5 min (aspirin tablets), but the majority of the tablets
have a maximum disintegration time of 30 min. Enteric
coated tablets are to show no evidence of disintegration
after 1 hour in simulated gastric fluid. The same tablets are
then tested in simulated intestinal fluid and are to
disintegrate in 2 hours plus the time specified in the
monograph.

Dissolution Test
In general, a single tablet is placed in a small wire mesh basket fastened to the bottom of the shaft
connected to a variable speed motor. The basket is immersed in the dissolution medium (as
specified in the monograph) contained in a 100 ml flask. The flask is cylindric with a hemispherical
bottom.
The flask is maintained at 37°C ± 0.5°C by a constant temperature bath. The motor is adjusted to
turn at the specified speed, and samples of the fluid are withdrawn at intervals to determine the
amount of drug in solution.
a. Apparatus-I (rotating basket dissolution apparatus):
Small wire mesh size basket – 22 u
Temperature - 37±5⁰c Rotated speed – 25-150 rpm u
Dissolution medium height from the bottom of the vessel – 23-27mm
b. Apparatus-2 (rotating paddle dissolution apparatus):
Small wire mesh size: 22 u
Dissolution medium height from the bottom of the vessel – 23-27mm u
Temperature - 37±5⁰c Rotated speed – 25-150 rpm

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Fig: USP Type1 Apparatus Fig: USP Type2 Apparatus

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S. No. Quantity/ No. of Acceptance Criteria

Stage level capsules
1. S1 6 All the tablets are NLT Q+5%
2 S2 6 Average of 12 tablets is ≥Q
No unit is less than Q-15%
3 S3 12 Average of 24 tablets is ≥Q
NMT 2 tablets are less than Q-15%
*NLT= Not Less Than, NMT= Not more than, Q= monograph toler

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AIM 5
TO PREDICT THE CONCENTRATION OF DRUG AFTER INTRAVENOUS
ADMINISTRATION FOLLOWING 1-CBM KINETICS FROM THE GIVEN
DATA
 THEORY:
 When a drug is given extravascularly, the drug moves in the human body through the
process of absorption, distribution, metabolism and elimination. However, the drug is
eliminated from the body completely after some time. The body is open with respect to the
drug movement.
 The movement of the drug in the body can be described with the help of a mathematical
model.
The one compartment open model, the simplest of the models, depicts the body as a single
homogenous unit. This model is particularly useful for drugs which rapidly distribute between
plasma and other body fluids and tissues upon entry into the systemic circulation.
 ASSUMPTIONS:
 The process of drug absorption from the absorption site may be explained by the first order
kinetics.
Explanation: Most drugs are absorbed by a passive diffusion mechanism that is governed by the
first order process i.e., the rate of drug absorption is proportional to the drug concentration at the
site of absorption. For drugs which are absorbed solely by active transport, facilitated diffusion
etc., this assumption is not valid.
 Once a drug enters the systemic circulation, it rapidly distributes to other body fluids and
tissue, and a dynamic equilibrium is achieved instantaneously between the drug in the blood and
the drug in other tissues.
Explanation: The drug which distributes to highly perfused tissues like the heart, lungs, liver,
kidney, etc., can distribute quickly and attain equilibrium between the drug levels in the plasma
and other body fluids and tissues. If the drug is distributed to poorly perfused tissues, the time
required for its distribution and equilibrium may be considerable. Hence, this simple-model is not
useful for pharmacokinetic analysis of the data obtained with such drugs.
 Any changes that occur in the plasma levels of a drug reflect proportional changes in the tissue
drug levels.
Explanation: Since there exists a dynamic equilibrium between drug concentration in the plasma
and drug concentration in the tissues, a change in the drug level of the plasma certainly brings a
proportional change in the levels of the tissue.
 Elimination of the drug from the body follows apparent first order kinetics and its rate
constant, K, is known as an apparent first order rate constant
Explanation: Drug elimination can occur from the body by many processes, including renal,
biliary, biotransformation, excretion in the expired air, etc.
 Intravenous Injection (Bolus)
When a drug is given in the form of a rapid intravenous injection (I.V. bolus), the entire dose of
the drug enters the body immediately. In most cases the drug distributes via the circulatory
system to all the tissues in the body and equilibrates rapidly in the body. The biological fluid
selected for study and drug form measured in it, are to be considered for developing suitable
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equations.
o I.V. Bolus - Unchanged Drug in Blood/Plasma
The schematic representation of drug movement in the body
in this case is shown:

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Where:
X0 = Dose of drug injected, X = Amount of drug present in body at any time 't', Vd=
Apparent volume of distribution of drug, C = Concentration of drug in central compartment
(plasma) at any time 't' , K = Apparent overall first order elimination rate constant.
Following I.V. bolus, the entire dose is in the body and is eliminated from the body by an
apparent first order process. The rate of decrease of the amount of the drug in the body is only
dependent upon the amount of the drug present in the body at any given time following LV.
bolus. Thus, we can write as follows,

𝑑𝑋 𝛼𝑋
𝑑𝑡
dX/dt is the rate of change of the drug amount in the body with respect to time.
𝑑𝑋
= −𝐾𝑋 - (1)
𝑑𝑡
where 'K' is a first order rate constant and the negative sign indicates that the drug is being lost
from the body.
To describe the time course of the amount of the drug in the body after injection, equation (1)
must be integrated after separating the variables.
𝑡
𝑑𝑋 𝑡
∫ = ∫ −𝐾𝑑𝑡
0 𝑑𝑡 0
| ln 𝑋 |𝑡 = −𝐾 |𝑡 |𝑡
0 0
ln 𝑋 − ln 𝑋0 = −𝐾 (𝑡 − 0)
ln 𝑋 = ln 𝑋0 − 𝑘𝑡

By applying logarithms,
log X = log 𝑋0 – Kt/2.303
Or
X = 𝑋 * e-kt
Where, 'e' represents the base of natural logarithm0
Since X = Vd. C
Substituting the values of 'X'
log C = log C0 – kt/2.303

Where: C = Concentration of drug in plasma at any time "t'

Co = Concentration of drug in plasma at time, t = 0

 Given:

X0 = 0.25 g
Vd = 10 l
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t1/2 = 5 hrs
K= 0.101 hr-1
 Formulas used:
 X= Vd.C
 C = C0.e-kt
 Log C = Log C0 – kt/2.303
 Vd = X/C
 t1/2 = 0.693/K
 Clr = Vd.K

 Calculations:
X0 = Vd. C
So, C0 = X0/Vd = 0.25 / 10
= 0.025g or 25 mg
Observation table:

Graphs:
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Time (hr) e-kt C=C0 e-kt log C

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0 1 25 1.397940009
1 0.903933 22.59832582 1.354076266
2 0.817095 20.4273732 1.310212523
3 0.738599 18.46497741 1.266348781
4 0.667644 16.69110303 1.222485038
5 0.603506 15.08763939 1.178621295
6 0.545529 13.63821563 1.134757553
8 0.445749 11.14371682 1.047030067
10 0.364219 9.105474489 0.959302582
12 0.297601 7.440037022 0.871575097
14 0.243169 6.079216514 0.783847611
16 0.198692 4.96729698 0.696120126
20 0.132655 3.316386627 0.520665155
24 0.088567 2.214166035 0.345210185
28 0.059131 1.478274937 0.169755214
32 0.039478 0.986961571 -0.005699757
36 0.026358 0.658939091 -0.181154728

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Conc. vs t
30

25
conc. (mg)

20

15

10

0
0 5 10 15 20 25 30 35 40

t (hr)

log C vs t
1.6
1.4 y = -0.0439x + 1.3979

1.2 R² = 1

1
log C

0.8

0.6

0.4 10 20 30 40
0.2
t (hr)

PK Parameters
calculated from
Graph using Excel
Slope= 0.00688208
K= 0.10100958 hr-
1

t1/2 = 6.86138614
hrs
Log C0 1.39794001
=
C0= 25 mg
Vd= 10 l
Clr= 1.0100958 lhr-
1

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AIM 6

TO SIMULATE SERUM LEVEL PROFILE OF DRUG OBEYING 1-CBM

WHEN ADMINISTERED I.V. INFUSION

 THEORY:
 I.V. drug solutions may be given either as a bolus dose or infused slowly at a constant rate
(zero- order rate). Drugs are given by I.V. infusion for the precise control of the plasma drug
levels, as per the needs of the patient.
 For drugs with a narrow therapeutic window, plasma drug levels can be maintained without
many fluctuations by IV. infusion. Many drugs can be administered with IV. fluids, including
electrolytes and nutrients.
 Another important advantage with IV. infusion is that the duration of drug therapy
may be maintained for a longer time and may be terminated when desired.
 During IV. infusion, the drug concentration slowly increases as the time proceeds and
reaches a steady state concentration or plateau level.
 The rate of drug infusion into the body is a zero order process i.e., drug reaches blood at a
constant rate, KO. At the steady state, the rate of the drug leaving the body, is equal to the rate of
the drug (infusion rate) entering the body. This drug level is maintained as along as the infusion
is continued.
 I.V. Infusion - Unchanged drug in Blood/Plasma

Where, KO = infusion rate (zero order) mg/hr.

The change in the amount of the drug in the body at any time (dX/dt) during the infusion is the
rate of input minus the rate of output.
𝑑𝑋
= 𝐾0 − 𝐾𝑋
𝑑𝑡
Dividing the entire equation by the volume of distribution of the drug, Vd, we get the following
equation.

𝑑𝑋/𝑉𝑑 𝐾0 𝐾𝑋
= −
Since C = X/Vd 𝑑𝑡 𝑉� 𝑉𝑑
�
𝑑𝐶 𝐾0
So, = − 𝐾𝐶 - (2)
𝑑𝑡 𝑉𝑑

Rearranging and multiplying with ekt

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𝑑𝐶 𝐾0
𝑒𝑘𝑡 + 𝐾𝐶 𝑒𝑘𝑡 = 𝑒𝑘𝑡
𝑑𝑡 𝑉𝑑

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Integrating between the limits of t = zero to t = t, and on simplification of the resultant equation,
we get the following equation,
𝐾0 𝑒𝑘𝑡 1
𝐶𝑒𝑘𝑡 = ( − )
𝑉� 𝐾 𝐾
Dividing by 𝑒𝑘𝑡 and �
simplifying,
𝐾0
𝐶= ( 1 − 𝑒𝑘𝑡) (3)
From equation (2), 𝑉𝑑 𝐾

𝑑 𝐾0
= − 𝐾𝐶
𝐶
𝑉�
𝑑𝐶
at steady state = 0, so, 𝑑𝑡 �
𝑑𝑡

𝐾0
− 𝐾𝐶𝑠𝑠 = 0
𝑉𝑑
𝐾0
= 𝐾𝐶𝑠𝑠
𝑉𝑑
𝐾0
𝐶𝑠𝑠 =
𝑉𝑑. 𝐾
From (3),
𝐶 = 𝐶𝑠𝑠( 1 − 𝑒𝑘𝑡)

Given:
K0 = 8 mg/hr
Vd = 20 l
K = 0.1 hr-1

 Formulas used:
 𝐾0
𝐶𝑠𝑠 = 𝑉𝑑.𝐾
 t1/2 = 0.693/K
 Clr = Vd.K

 Calculation:
𝐶𝑠 𝐾0
𝑠 = 𝑉𝑑.𝐾

Observation table:

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= 8/(20 * 0.1)
= 4 mg/l

Time (hr) (-kt) e(-kt) 1- e(-kt) C=Css(1- e(-kt)))

0 0 1 0 0
1 -0.1 0.904837418 0.095162582 0.380650328
2 -0.2 0.818730753 0.181269247 0.725076988

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3 -0.3 0.740818221 0.259181779 1.036727117

4 -0.4 0.670320046 0.329679954 1.318719816
5 -0.5 0.60653066 0.39346934 1.573877361
6 -0.6 0.548811636 0.451188364 1.804753456
8 -0.8 0.449328964 0.550671036 2.202684144
10 -1 0.367879441 0.632120559 2.528482235
12 -1.2 0.301194212 0.698805788 2.795223152
14 -1.4 0.246596964 0.753403036 3.013612144
16 -1.6 0.201896518 0.798103482 3.192413928
20 -2 0.135335283 0.864664717 3.458658867
24 -2.4 0.090717953 0.909282047 3.637128187
28 -2.8 0.060810063 0.939189937 3.756759749
32 -3.2 0.040762204 0.959237796 3.836951184
36 -3.6 0.027323722 0.972676278 3.89070511
Graphs

Conc vs. 1-e^-kt

4.5
4

3.5
conc. (mg)

3 y = 4x

2.5 R² = 1

1.5
0 0.2 0.4 0.6 0.8 1 1.2
1-e^(-kt)

Parameters calculated
from graph using
Excel
Css=slope 4
K= 0.1 hr-1
t 1/2= 6.93 hr
Clr= 2 l/hr

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AIM 7

TO SIMULATE SERUM LEVEL PROFILE OF DRUG OBEYING 1-CBM

WHEN ADMINISTERED I.V. INFUSION
 Given:
K0 = 5 mg/hr
Vd = 17.8 l
K = 0.5 hr-1

 Formulas used:
 𝐾0
𝐶𝑠𝑠 = 𝑉𝑑.𝐾
 t1/2 = 0.693/K
Clr = Vdk

Calculation:
𝐾0
𝐶𝑠 = 𝑉𝑑.𝐾
𝑠
= 5/(17.8 * 0.5)
= 0.561 mg/l

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Observation table:

Time (hr) (-kt) e(-kt) 1- e(-kt) C=Css(1- e(-kt)))

0 0 1 0 0
1 -0.5 0.60653066 0.39346934 0.2207363
2 -1 0.36787944 0.632120559 0.354619634
3 -1.5 0.22313016 0.77686984 0.43582398
4 -2 0.13533528 0.864664717 0.485076906
5 -2.5 0.082085 0.917915001 0.514950316
6 -3 0.04978707 0.950212932 0.533069455
8 -4 0.01831564 0.981684361 0.550724927
10 -5 0.00673795 0.993262053 0.557220012
12 -6 0.00247875 0.997521248 0.55960942
14 -7 0.00091188 0.999088118 0.560488434
16 -8 0.00033546 0.999664537 0.560811805
20 -10 4.54E-05 0.9999546 0.560974531
24 -12 6.1442E-06 0.999993856 0.560996553
28 -14 8.3153E-07 0.999999168 0.560999534
32 -16 1.1254E-07 0.999999887 0.560999937
36 -18 1.523E-08 0.999999985 0.560999991

Graphs

Conc. vs t
0.6
0.5
conc. (mg)

0.4

0.3

0.2

0.1

0
0 10 20 30 40
t (hr)

32
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Conc. vs 1-e^(-kt)
0.6
0.5

0.4
y = 0.561x - 1E-15
conc. (mg)

0.3
R² = 1
0.2
0.1

0
0.2 0.4 0.6 0.8 1 1.2
0
-0.1
1-e^(-kt)

Parameters calculated from graph using Excel

Css=slope 0.561
k= 0.500711 hr-1
t 1/2= 1.384032 hr
Clr= 8.912656 l/hr

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