University of Basrah

College of Pharmacy

This project is submitted to the department of pharmaceutics

as a partial fulfilment for graduation in college of pharmacy

By:
Nasser Salman Nasser
Zainab Reah Najim
Huda Muslim Jekheour

(5th stage)

Supervised by:
Ass. Prof. Dr. Ahmed Najim Abood

2022-2023

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 Table of contents:

No. Subject Page

Abstract 3
1 Introduction 4
1.1 Classification of tablets dosage form 4
1.2 Advantages 4
1.3 Disadvantages 5
1.4 Evaluation 5
1.4.1 Official tests 5
1.4.2 Non-official tests 7
1.5 Drug under investigation (Ibuprofen) 8
2 Experimental work 9
2.1 Materials 9
2.2 Equipment’s 9
2.3 Methods 10
2.3.1 Weight variation test 10
2.3.2 Content uniformity test 10
2.3.3 Disintegration time 10
2.3.4 Dissolution test 11
2.3.5 General Inspection 11
2.3.6 Thickness and diameter measurements 11
2.3.7 Hardness test 11
2.3.8 Friability test 11
3 Results and discussion 12
3.1 Weight variation test 12
3.2 Content uniformity test 14
3.3 Disintegration time 16
3.4 Dissolution test 16
3.5 General Inspection 17
3.6 Thickness and diameter measurements 18
3.7 Friability test 20
4 Conclusions 21
5 Acknowledgement 21
6 References 22

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 ABSTRACT
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that possesses anti-
inflammatory, analgesic, and antipyretic effects and it is widely marketed in the
Republic of Iraq.

The study aims to evaluate the in vitro quality of four ibuprofen (film and sugar)
coated tablets 400mg formulations that are commercially most commonly used in the
Republic of Iraq markets.

Ibuprofen tablets were tested include non-pharmacopoeia (non-official) tests like

organoleptic properties, friability, thickness, diameter and hardness, and some
pharmacopoeia (official) tests according to USP like the uniformity of weight,
disintegration time, dissolution, and analysis of the drug active content with the UV
spectrophotometric method following comparisons with official protocols and
pharmacopeia monograph.

Our data indicated that the Ibuprofen tablet investigated in our study meets the in
vitro quality control meets the official specifications, is chemically equivalent, and does
not vary in physiochemical qualities.

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 1. Introduction
According to united states pharmacopeia (USP), tablets are solid, flat or biconvex
unit dosage form of a medicament alone or medicament along with excipients prepared
by compressing technique. They may vary in size, shape and weight depending on the
medicament and its mode of administration.

Tablets are said to be most widely used conventional dosage forms due to its variety
of advantages and 70% of the medicaments were dispensed in tablet forms. Most of the
medicaments can be processed into tablets but there are some exceptions like
medicaments with low density characters, hygroscopic and the medicaments which
were not possible to administer. Post-compression studies (Evaluation parameters)
plays a major role to release any dosage form into the market. [1]

1.1 Classification of tablets dosage form [2]

Tablets are classified according to their routes of administration or functions. The

following are the four main classification groups:-

A. Tablets ingested orally:

Ex: Compressed tablets and coated tablets
B. Tablets used in the oral cavity:
Ex: Sublingual tablets, buccal tablets.
C. Tablets administered by other routes:
Ex. Implantation tablets and vaginal tablets
D. Tablets used to prepare solutions:
Ex: Effervescent tablets and dispensing tablets.
1.2 Advantages [3]
As advantages of tablet over other oral dosage form, we have:
 Unit dosage forms with dose precision.
 Least content variability.

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  Administration of accurate amounts of minute doses of a drug is possible.
 Economical of all oral dosage forms as its production doesn't requires additional
processing steps.
 Easy transportation.
 Sustain release of a drug can be achieved through enteric coating.
 Medicaments with bitter taste can be masked with coating technique (Sugar
coating).
 Tablet dosage form is stable when compared to all oral dosage forms.

1.3 Disadvantages [4]

 Administration of drugs is not easy in case of children.
 Drugs with slow dissolution is not acceptable for tableting with good
bioavailability.
 Medicaments with low density characters and amorphous in nature are difficult to
compress.
 Hygroscopic nature of drugs is not acceptable for tablet compression.

1.4 Evaluation
In pharmacy, the aim of evaluation of tablets is to ensure safety, potency, efficacy,
stability, Patient acceptability and patient compliance of tablet, check whether a
pharmaceutical tablet satisfy certain standards to claim it to be a quality drug or not,
check that the quality parameters are within the acceptance limits or not.

Generally, the evaluation of tablets is done using a number of tests which can be
classified into:

1.4.1 The official tests [8]

 Weight variation test
Tablets generally are manufactured to contain a certain amount of active ingredients in
a certain weight of tablet. Allowed limits according to U.S.P are shown in figure (1).

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 Figure (1): USP Allowance limits for weight variation test

 Content Uniformity Test

Determines the amount of drug in a sample of tablets. For tablets in which the
active ingredients make up about 90% of the tablet weight, the weight variation test will
give a good measure of content uniformity depending on the following criteria:

❑ The acceptable potency range for (low-dose, highly potent drugs) = 90%-110%.

❑ For large-dose drugs, the range is 95%-105% of the labelled amount.

❑ No tablet should fall in the range of 75 – 125% deviation (tablets then classified
as under-doses or over-dosed).

 Disintegration Test
The first thing that happens to tablets before absorption is disintegration, or breaking
down to granules and small particles before dissolving (dissolution) in the gastric fluid.

For absorption to take place, dissolution of the drug in the gastrointestinal fluid
has to occur, since only the drug in solution is absorbed.

The time it takes to disintegrate is called disintegration time which can be

experimentally measured by a USP disintegration apparatus.

 Dissolution
Dissolution is the process by which a solid solute enters a solution.
Pharmaceutically, it may be defined as the amount of drug substance that goes into

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 solution per unit time under standardized conditions of liquid/solid interface,
temperature and solvent composition. Dissolution kinetics is important in determining
the bioavailability of a drug.

1.4.2 Non-official tests [9]

 General Inspection
Includes a visual inspection and identification for any flaws that may affect the
appearance for several reasons such as:

❑ To control and check batch to batch uniformity.

❑ To control any manufacturing issues.

❑ To ensure consumer acceptance.

This inspection includes organoleptic properties of tablet like colour, odour, any
physical flaws…. etc.

Many pharmaceutical tablets use the colour as vital means of rapid identification
and consumer acceptance. The color of a product must be uniform within a single
tablet.

 Size and shape

Measured by:
 Micrometer
 Sliding calliper scale
Tablet thickness should be controlled within +5% variation of standard value.
More likely to cause capping problem.
 Hardness Test
Hardness is generally expressed as the force required to break a tablet in a
diametric compression test; it is often called breaking strength or tablet crushing
strength and can be measured using hardness tester.

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  Friability Test

Friability is a measure of the tendency of a tablet to powder, chip, and fragment

during handling and is another measure of tablet strength, can be measured using the
friability tester.

1.5 Drug under investigation (Ibuprofen)

Ibuprofen is a nonsteroidal anti-inflammatory drug. It is non-selective COX

inhibitor, which means it inhibits both COX-1 and COX-2 enzymes. COX-2 inhibition
leads to decreases in production of prostaglandins which is responsible for the
transmission of pain signals in the body and mediating inflammation, fever and
swelling.

It is used to reduce fever and treat pain or inflammation caused by many conditions such
as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury. [3]

Table (1) illustrate the physicochemical properties of Ibuprofen.

Table (1)

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 Ibuprofen is a carboxylic acid (Propionic acid derivative), as seen in its chemical
structure, figure (2), has a relatively high lipophilicity and shows poor solubility in an
aqueous media this due to the presence of the non-polar alkyl groups and benzene ring
which significantly reduces the polarity of the ibuprofen molecule. Ibuprofen is soluble
in organic solvents such as ethanol, DMSO, and dimethyl formamide. The solubility of
(±)-ibuprofen in these solvents is approximately 60, 50, and 45 mg/ml, respectively.

Figure (2): The chemical structure of Ibuprofen

The main objective of study was to evaluate the commercially available Ibuprofen
tablets using different tests include non-pharmacopoeial (non-official) tests like
organoleptic properties, friability, thickness, diameter and hardness, and some
pharmacopoeial (official) tests according to USP like weight variation , content
uniformity , In vitro disintegration and dissolution tests.

2. Experimental work
2.1 Materials
Film and sugar Ibuprofen coated tablets (strength of 400 mg) of four different
companies coded as (A, B, C, and D), absolute ethanol, distilled water, monosodium
phosphate and disodium phosphate.

2.2 Equipment (see appendix I)

Sensitive balance (G&G), UV-visible spectrophotometer (Cecil), disintegration
apparatus (Copley), double drum friability tester (Copley), hardness tester (ERWEKA),
Digital calliper (Copley) and dissolution apparatus.

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 2.3 Methods
2.3.1 Weight Variation Test
Twenty tablets were taken randomly of each company and measure the weight of
each tablet individually.
Individual weights are compared with the average weight. If no more than two
tablets are outside the percentage limit, and if no tablet differs by more than two times
the percentage limit, the tablets pass the USP weight variation tests.[5]
2.3.2 Content Uniformity Test
Select randomly a 10 tablets-sample of each company, then examine each tablet
individually, grind it and transfer into 100 ml volumetric flask. Then dissolve in 100ml
(99.99%) ethanol and filter the resultant solution.

Dilute 1 ml of filtrate in suitable volume of ethanol and measure the absorbance of

the resulting solution at 263.5 nm. Use the calibration curve to calculate the recovered
concentration of ibuprofen and use dilution factor to calculate the amount of active
ingredients in each tablet. Finally compare the recovered amount of active ingredient
the allowed deviation percentage which stated in USP. (The allowed percentage is ±15%
of the stated potency). [6]

2.3.3 Disintegration Test

To carry out a disintegration test for tablets, we use the U.S.P. device
(disintegrator) in which six glass tubes that are 3 inches in length; open at the top and
10 mesh screen at the bottom end. To estimate disintegration time, six tablets were
randomly taken from 18 tablets of each company, 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 ± 2°, then raised and lowered into a beaker of water. If
the tablets float, perforated plastic disks are placed on the top of the tablets to keep them
under the water level. The tablet disintegration time is taken when no residue is left in
the mesh. Unless otherwise stated in the individual monograph film-coated tablets
disintegrate within 30 minutes and other coated tablets disintegrate within 60 minutes.

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 2.3.4 Dissolution Test
This test determines the amount of active ingredient(s) released from a solid oral
dosage form, under controlled conditions (Temp. about 37C, stirring speed= 50rpm at
900ml of phosphate buffer (pH =7.4) within a predetermined length of time).

One tablet of each companies was taken (this due to short time and lack of required
materials in sufficient quantities), then was put in single jar of dissolution tester.
Dissolution apparatus start for 30min, after that withdraw sample from each jar and
filtered it. Then assay by UV spectrophotometer employing UV absorption at the
estimated wave length of maximum absorbance. Then the prepared calibration curve
was used to obtain the concentration for each. [2]

Tolerance of test was not less than 80% of the labelled amount of ibuprofen is dissolved
in 30 min.

2.3.5 General Inspection

Visual inspection and identification for any flaws that may affect the appearance.

2.3.6 Thickness and Diameter Tests

Twenty tablets were randomly taken for each company and measure thickness
and diameter of each tablet individually with a digital calliper and then obtain the
average thickness and diameter and percentage of deviation. Thickness and diameter
should be within ± 5% variation of a standard value.

2.3.7 Hardness Test

Six tablets were placed individually between two anvils, force is applied to the anvils
by using hardness tester & the crushing strength that just causes the tablet to break is
recorded (in kg). Tablet hardness should be between 6 – 10 kg in range.

2.3.8 Friability test

Twenty tablets were randomly selected and weighed by the sensitive digital
balance to read pre-test weight. Then we put the tablet in friabilator to rotate them for 4

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 minutes (100 rotate). After that, we take the tablets out of the machine and try to clean
them with a brush from crumbs and dust, then we weigh the tablets again by balance to
obtain post-test weight. The weight loss% was calculated by the following equation:

Weight loss% = (W1 - W2/W1) *100% ------------------------------- (1)

w1= Initial weight of tablets or pre-test weight.

w2= Final weight of tablets or post-test weight.

Friability Limits: According to USP, IP and BP, it should be not more than 1.0%.

3. Results and discussion

In our study, Ibuprofen tablets 400mg of four different companies (A, B, C, and
D) have been evaluated through official and non-official tests. These tests were
performed by use standard equipment and methods.

3.1 Weight variation test

The purpose of this test is to make sure that the entire tablets under observation
have uniformity in weight and have the required amount of labelled drug.

The acceptable range of weight variation for ibuprofen 400mg tablets should follow
deviation percentage =5%.

The weight of each of twenty ibuprofen tablets of each company was measured as well
as the standard of deviation. The results are listed in Table (2).

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 Table (2)

No. A (Tablet wt. B (Tablet wt. C (Tablet wt. D (Tablet wt.

in g) in g) in g) in g)
Tab 1 0.591 0.638 0.638 0.877
Tab 2 0.592 0.650 0.633 0.863
Tab 3 0.581 0.644 0.637 0.848
Tab 4 0.575 0.631 0.635 0.875
Tab 5 0.574 0.641 0.642 0.891
Tab 6 0.567 0.636 0.634 0.900
Tab 7 0.579 0.647 0.633 0.877
Tab 8 0.580 0.635 0.628 0.833
Tab 9 0.579 0.639 0.639 0.840
Tab 10 0.576 0.640 0.644 0.894
Tab 11 0.580 0.650 0.643 0.848
Tab 12 0.577 0.642 0.636 0.844
Tab 13 0.577 0.645 0.626 0.891
Tab 14 0.579 0.637 0.637 0.900
Tab 15 0.572 0.645 0.635 0.897
Tab 16 0.588 0.638 0.637 0.885
Tab 17 0.576 0.651 0.642 0.909
Tab 18 0.586 0.643 0.641 0.827
Tab 19 0.581 0.646 0.637 0.838
Tab 20 0.586 0.646 0.632 0.868
Av.wt 0.580 0.642 0.636 0.870
Accepted 0.551-0.609 0.610-0.674 0.604-0.668 0.827-0.914
Range (+ 5%)

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 The results indicate that all tablets of each company were within USP weight limits.
The lowest weight variation was found among tablets of company (C). The reasons of
low weight variation between tablets attributed to good flowability, uniform size and
shape of powder particles and the appropriate amount and type of excipients. The
company (D) showed variation in weight more than other companies but is still within
accepted range of USP.

3.2 Content uniformity test

This test was performed to ensure that every tablet contains the same amount of drug
substance with a defined allowed variation within a batch. Calibration curve of
Ibuprofen in ethanol, figure (3)-a, was used to estimate the required concentration of
ibuprofen that present in each tablet.

a. Ethanol

Figure (3): Calibration curves of Ibuprofen in (a) ethanol and (b) phosphate
buffer

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 The results of content uniformity test were illustrated in Table (3).
Table (3)
No. A (%) B (%) C (%) D (%)

Tab 1 100 96 97 98
Tab 2 98 107 91 100
Tab 3 92 107 91 86
Tab 4 86 88 96 86
Tab 5 87 88 91 95
Tab 6 85 96 96 90
Tab 7 97 103 96 96
Tab 8 94 86 96 88
Tab 9 100 86 95 85
Tab 10 102 99 92 89
Av. 94.1% 95.6% 94.1% 91.3%

The average of percentage of content of 10 tablets of Company (A) is 94.1%,

company (B) is 95.6%, company (C) is 94.1% and (D) is 91.3%. Depending on the
acceptable range stipulated by USP (85% - 115%), all tablets of the four companies
showed acceptable results. This indicate good uniformity of drug in the prepared tablets.

Although tablets of company B with highest average percentage of content but they
show variation in drug content among ten tablets in range (86 -107%). While tablet of
company C showed better results, where all tablets within range (91-97%).

The range (85-115%) reflect the acceptable percentage of content that limit
effectiveness of drug, less than 115% is effective drug and nontoxic and less than 85%
is nontoxic but not provide therapeutic effect.

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 3.3 Disintegration time

The obtained results showed that the four brands tablets were disintegrated within
the accepted disintegration time (30min). The results reflected fast disintegration time
values as seen in Table (4). The faster disintegration time will improve the dissolution
rate and this enhance absorption and bioavailability and provide rapid onset of action
and response.

Table (4)

Tablet Disintegration Disintegration Disintegration Disintegration

time for A (min) time for B (min) time for C (min) time for D (min)
Av. Time of 6 1.53min 1.45min 2.03min 2.3min
tablet

The good results of this test may be due to several factors such as: amount and
type of disintegrant that used in formula, in addition to type and amount of lubricant,
binder and compression force.

3.4 Dissolution Test

Dissolution is the process in which a substance forms a solution. Dissolution

testing measures the extent and rate of solution formation from a dosage form. The
dissolution of a drug is important for its bioavailability and therapeutic effectiveness.
To evaluate the dissolution of drug products properly, it is critical for procedures to be
standardized. This standardization helps to show consistent quality in production and
may serve as a predictive measure of efficacy. The calibration curve, figure (4), will be
used to obtain the amount that released from tablet after 30min:

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 b. Phosphate buffer

Figure (4): Calibration curve of Ibuprofen in phosphate buffer (pH = 7.4)

Acceptance criteria of dissolution test is =Q+5%, Q= the amount of drug that

should dissolved in certain time. Each drug has different Q according USP. Q-value of
ibuprofen is 80% so the acceptable criteria must all tablets not less than 85%. Based on
this limit so all obtained results of four companies are accepted as seen in Table (4). The
amount that is obtained from dissolution test after 30min is high and exceed 100٪ this
may be attributed to tablets that show more than 100% in content uniformity. Company
(B) show high result in dissolution and content but it is still within acceptable limit.
Higher dissolution results reflected higher bioavailability.

Table (5)

Time in min A (%) B (%) C (%) D (%)

30 min 101% 109% 102% 105%

3.5 General Inspection

Appearance is the first most required quality for the acceptance of tablet. General
elegance and its identity play a major role for the consumer acceptance. Acceptance of
the appearance of batches of the tablet has been done based on the measurement of the
following factors like colour, shape, presence or absence of odour and taste.[4]

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 After examination of tablets, the following observation were obtained:
Company A: Round, dark pink film coated tablets with regular edges. The tablets
without a break-line and any engraving. There are no unacceptable odour and taste.

Company B: Oval pink film coated tablets with regular edges. Without a break -line
and any engraving. With acceptable odour and slightly bitter taste.

Company C: Round pink film coated tablets with regular edges. On its surface there is
an engraving (400). With acceptable odour and taste.

Company D: Round, white sugar-coated tablets with regular edges. With Sweet taste
and acceptable odour. Without break line and any engraving.

The tablets of each company have a good appearance, this may be attributed to
the coating, which provides taste masking, odour and gives a smooth finish to the
product and makes it easy to swallow. The coating enhances product acceptance and the
appearance of the tablet. [7]

Appearance properties are very important to identification and acceptance by

patients. In addition to that are markers for tablets stability for example the presence of
odour in a batch of tablet indicates a stability problem.

3.6 Thickness and diameter measurements

The experiment is conducted to test the uniformity of the tablets thickness

and diameter. The obtained result listed in Table (6):

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 Table (6)

No. A A B C C D D
Thickness Diameter Thickness Thickness Diameter Thickness Diameter
(mm) (mm) (mm) (mm) (mm) (mm) (mm)
Tab 1 7.67 12.86 6.60 5.59 13 7.67 13.56
Tab 2 7.84 12.85 6.63 5.61 12.99 7.84 13.53
Tab 3 7.88 12.88 6.56 5.57 13 7.88 13.57
Tab 4 7.78 12.86 6.59 5.59 13.08 7.78 13.53
Tab 5 7.85 12.87 6.49 5.61 12.99 7.85 13.58
Tab 6 7.82 12.88 6.57 5.57 13.06 7.82 13.56
Tab 7 7.82 12.87 6.59 5.55 13.01 7.82 13.56
Tab 8 7.99 12.86 6.58 5.6 12.97 7.99 13.5
Tab 9 7.75 12.88 6.58 5.58 12.99 7.75 13.58
Tab 10 7.75 12.88 6.58 5.58 12.93 7.75 13.56
Tab 11 7.76 12.84 6.56 5.6 13.04 7.8 13.53
Tab 12 7.98 12.86 6.6 5.6 13.04 7.98 13.52
Tab 13 7.91 12.86 6.58 5.58 13.01 7.91 13.55
Tab 14 7.8 12.86 6.6 5.61 12.96 7.8 13.53
Tab 15 7.78 12.86 6.58 5.62 12.93 7.78 13.57
Tab 16 8.02 12.87 6.62 5.58 13.02 8.02 13.53
Tab 17 7.86 12.85 6.61 5.61 13 7.86 13.51
Tab 18 7.7 12.87 6.56 5.6 13 7.7 13.53
Tab 19 7.72 12.83 6.62 5.62 13.06 7.72 13.56
Tab 20 7.65 12.86 6.62 5.62 12.98 7.65 13.57
Av.Thickness 7.8165 12.8625 6.586 5.5945 13.003 7.8185 13.5465
& Diameter
(mm)

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 Tablet thickness and diameter should be within a ±5% deviation of a standard
value. Deviation % calculate by this equation:

𝑖𝑛𝑑𝑖𝑣𝑖𝑑𝑢𝑎𝑙 𝑑𝑖𝑎𝑚𝑒𝑡𝑒𝑟 𝑜𝑟 𝑡ℎ𝑖𝑐𝑘𝑛𝑒𝑠𝑠 − 𝐴𝑣𝑒𝑟𝑎𝑔𝑒

𝐷𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 % = ∗ 100%
𝐴𝑣𝑒𝑟𝑎𝑔𝑒

The result shows small value of difference which indicate the tablets are uniform
in their thickness and diameter. Thickness and diameter must be controlled. The
uniformity in diameter and thickness of tablets is very important to increase the patient
compliance and avoid them from being confused with different sizes of the tablets.
Different sizes of the tablets may cause the patient to think that the drugs or tablets have
different amount of active ingredient.

Thickness of a tablet is determined by the diameter of the die, the amount of fill
permitted to enter the die, the compaction characteristics of the fill material, and the
force or pressure applied during compression. Many of these factors are affected by the
flow properties of powders, size and shape of particles and the amount and type of
excipients (glidants). To produce tablets of uniform thickness during and between batch
productions for the same formulation, care must be exercised to employ the same factors
of fill, die, and pressure.

3.7 Friability test

Is used to test the durability of tablets during packaging processes and transit.
This test performed to determine the mechanical strength of tablets through measuring
the weight loss %. According to USP, a maximum weight loss not more than 1.0 % is
considered acceptable. The results obtained from this test of companies as shown in
Table (7), were all less than 1%. This indicates that tablets have high resistance to loss
of weight so that tablets have ability to withstand abrasion in handling, packaging and
shipment.

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 Table (7)

Weight for A Weight for B Weight for C Weight for D

(gm) (gm) (gm) (gm)
Initial wt. 11.6394 12.9852 12.8699 17.4148
Wt. After test 11.6370 12.9825 12.8693 17.4140
Weight loss % 0.0206 % 0.0208 % 0.00466 % 0.00459 %
Accepted Accepted Accepted Accepted

The good mechanical properties of these tablets it is attributed to sugar and film
coated. Coating provides stability to the tablets in handling and prevents them from
sticking together. The coating also improves the hardness of the tablets.

We note that the lowest weight lost was from the company (D) this is due to that
company D tablets are sugar coated. Sugar coating is a multistage process in which a
thick and hard sugar coat is spread over the surface of tablets. While film coating is
single stage process including spread a thin layer over the surface of tablets.

4. Conclusions

From the laboratory work that we conducted for a number of companies available
in local pharmacies, it was found that the results of all these evaluation tests of different
companies of Ibuprofen tablets were within the pharmacopoeia limits so it could be
concluded that marketed pharmaceutical tablets of Ibuprofen of these brands satisfy
quality control limits of pharmacopoeia.

5. Acknowledgement

Praise be to the Lord of the world (Allah), and prayer and peace upon the most
honoured prophets and messengers Mohammed and on his family and his companions
to the doomsday.

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 After that I'd like to thank Assist. Prof. Dr. Ahmed Najim Abood for his
significant support and guidance to perform and complete this project.

Also, I'd thank everyone who helped us with the project especially ph. Ahmed
Mohammed.

I extend my thanks and gratitude to the professors of the Pharmaceutics Branch

and the members of the project discussion committee.

6. References:
1. Loyd V. Allen, Jr. Howard C. Ansel. Ansel’s Pharmaceutical Dosage Forms and
Drug Delivery Systems. Allen, Loyd V., Jr. Tablet. Philadelphia. 2001.263-298
2. Kevin M. G. Taylor, Michael E. Aulton. Aulton’s Pharmaceutics. Göran
Alderborn. Tablets and compaction .1988. 504-550
3. Tripathi K. Non steroidal anti inflammatory drugs and anti pyretic analgesics.
Essentials of medical pharmacology. 2003;5:176
4. Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig. The Theory and
Practice of Industrial Pharmacy. GILBERT S. BANKER and NEIL R.
ANDERSON . Tablet . Philadelphia . 1986 . 293_345
5. Freeman, M. K., White, W., & Iranikhah, M. Tablet Splitting: A Review of
Weight and Content Uniformity. The consultant pharmacist. 2012, 27(5). 341-
352
6. Hiestand, E. N., Well, J. E., Pool, C. B., Ocks, J. F.: Physical processes of
tableting. J. Phaim. Sci. 1977, 66:510-519
7. Porter S.C. Coating of Pharmaceutical Dosage Forms. Remington; Madison, NC,
USA: Elsevier; Amsterdam, the Netherlands: 2021. pp. 551–564.
8. United States Pharmacopeia and National Formulary (USP 43–NF 38). United
States Pharmacopeial Convention; 2020.
9. Center for Drug Evaluation and Research (CDER) (2015). “Guidance for
Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and
Capsules”. United States Food and Drug Administration.

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 Appendix I

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