0% found this document useful (0 votes)
292 views37 pages

Ipqc

IPQC tablets involves quality control processes before, during, and after manufacturing tablets. Key in-process control parameters for tablets include weight variation, hardness, friability, drug content uniformity, disintegration, and dissolution. Official tests specified by pharmacopeias include weight variation, disintegration, dissolution, drug content, and friability. Non-official tests include size, shape, thickness, markings, and organoleptic properties. Dissolution testing is important to check the percentage of drug released from tablets and capsules under various conditions.

Uploaded by

Ajitha Azhakesan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
292 views37 pages

Ipqc

IPQC tablets involves quality control processes before, during, and after manufacturing tablets. Key in-process control parameters for tablets include weight variation, hardness, friability, drug content uniformity, disintegration, and dissolution. Official tests specified by pharmacopeias include weight variation, disintegration, dissolution, drug content, and friability. Non-official tests include size, shape, thickness, markings, and organoleptic properties. Dissolution testing is important to check the percentage of drug released from tablets and capsules under various conditions.

Uploaded by

Ajitha Azhakesan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 37

IPQC

TABLETS
 IPQC Before, After & During The
Manufacturing
 At Sampling Stage : Planning of sampling should be done
as per the Standard Operating Procedures (SOP)s which
describes the sampling methods. Sufficient quantity of
samples should be collected for Analysis.
 At Manufacturing Stage : Weighing or measuring of active
pharmaceutical ingredients, excipients, diluents or vehicle
should be done under the suitable conditions which do not
affect their conformity of use. Appropriate and calibrated
equipment / instrument should be used for the above
purpose.
 In Process Test Stage: In-process tests should be
performed on the sampled material. The quality control
dept. will be responsible for the testing. Samples are tested
by quality control personnel to verify conformance with
specifications within the acceptable limits.
Table: In-process Control Parameters
Official and Unofficial Tests for Evaluation of Tablets

Official Tests
1 Weight variation

2 Disintegration

3 Dissolution

4 Drug content

5 Friability

Non-Official Tests
1 Size and shape

2 Organo leptic

3 Thickness

4 Uniformity identification markings

5 Hardness
General Appearance:

-Size, shape, and thickness:


This is important to facilitate packaging and to decide
which tablet compressing machine to use.

-Organoleptic properties:
which include color, taste and odor of the tablets.
⦿ Thickness
can vary with no change in weight due to:

a. Difference in the density of the granulation


b. The pressure applied to the tablets.
c. The speed of tablet compression.
⦿ tablet thickness important in reproducing tablets
identical in appearance but also to insure that every
production lot will be usable with selected packaging
components.
⦿ If the tablets are thicker than specified, a given number
no longer may be contained in the volume of a given size
bottle.
⦿ A plus or minus 5% may be allowed, depending on the size
of
the tablet.
• Unique Identification Markings :

• Pharmaceutical companies often use some type of unique markings on


tablets in addition to color, for rapid identification of their product these
markings utilize some form of embossing, engraving or printing of the
company name or symbol or a product code.
Hardness
1. Hardness

Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shocks of
handling in manufacture, packaging and shipping. Hardness generally measures the tablet crushing strength.

Importance
 To determine the need for pressure adjustments on the tableting machine.
 Hardness can affect the disintegration.
 So if the tablet is too hard, it may not disintegrate in the required period of time.
And if the tablet is too soft, it will not withstand the handling during subsequent processing such as coating or
packaging.
 In general, if the tablet hardness is too high, we first check its disintegration before rejecting the batch.
 If the disintegration is within limit, we accept the batch.
 If Hardness is high + disintegration is within a time accept the batch.

Factors Affecting the Hardness


1 Compression of the tablet and compressive force.
2 Amount of binder. (More binder à more hardness)
3 Method of granulation in preparing the tablet (wet method gives more hardness than direct method, Slugging
method gives the best hardness).

Limits
5 kilograms minimum and 8 kilograms maximum.
Make hardness test on 5 tablets and then take the average hardness.
Friability
2. Friability
Friability of a tablet can determine in laboratory by Roche friabilator. This consist of a plastic chamber that revolves at 25 rpm,
dropping the tablets through a Distance of six inches in the friabilator, which is then operate for 100 revolutions. The tablets are
reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are consider acceptable.
Weight variation test (uniformity of weight)
1. Weight variation test (uniformity of weight)

Weigh 20 tablet selected at random, each one individually. X1, X2, X3… Xz

Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20 Limit:

 Upper limit = average weight + (average weight * % error)


 Lower limit = average weight - (average weight * % error)
 The individual weights are compared with the upper and lower limits.
 Not more than two of the tablets differ from the average weight by more than the
% error listed, and no tablet differs by more than double that percentage.

Weight Variation Tolerances for Uncoated Tablets

USP XX-NF STANDARDS


Sr. No Average wt. of tablet(mg) Max. % difference allowed
1 130 or Less 10%
2 130-324 7.5%
3 More than 324 5%

IP STANDARDS
Sr. No Average wt. of tablet(mg) Max. % difference allowed
1 84 or Less 10%
2 84-250 7.5%
3 More than 250 5%
Content Uniformity Test
2. Content Uniformity Test

Randomly select 30 tablets. 10 of these assayed individually. The Tablet

pass the test if 9 of the 10 tablets must contain not less than 85 % and not

more than 115 % of the labeled drug content

and the 10th tablet may not contain less than 75 % and more than125 % of

the labeled content.

If these conditions are not met, remaining 20 tablet assayed individually

and none may fall outside of the 85 to 115 % range.


Disintegration test (U.S.P.)
3. Disintegration test (U.S.P.)

 It is the time required for the tablet to break into particles, the disintegration test is a

measure only of the time required under a given set of conditions for a group of tablets

to disintegrate into particles.

 It is performed to identify the disintegration of tablet in particular time period.

 Disintegration test is not performed for controlled & sustained release tablets.

 According to the test the tablet 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.
Disintegration Testing Conditions and Interpretation
U.S.P. method for uncoated tablets
 Start the disintegration test on 6 tablets.
 If one or two tablets from the 6 tablets fail disintegrate completely within 30 min
repeat the same test on another 12 tablet. (i.e. the whole test will consume 18 tablets).
 Not less then 16 tablets disintegrate completely within the time
 If more than two tablets (from the 18) fail to disintegrate, the batch must be rejected.

For Coated tablets


 To remove or dissolve the coat, immerse the tablet in distilled water for 5min.
 Put the tablet in the apparatus in water or HCL for 30 min at 37oC (according to the U.S.P). If not
disintegrated, put in intestinal fluid.
 If one or two tablets fail to disintegrate, repeat on 12 tablets. So 16 tablets from the 18 must
completely disintegrate within the time, if two or more not disintegrated the batch is rejected.

U.S.P. and B.P Method for Enteric coated tablets


 Put in distilled water for five minutes to dissolve the coat.
 Then put in simulated gastric fluid (0.1M HCL) for one hour.
 Then put in simulated intestinal fluid for two hours.
 If one or two tablets fail to disintegrate, repeat this test on another 12 tablets. So 16
tablets from 18 should completely disintegrate. If more than two fail to disintegrate the Batch must
be rejected.
Dissolution Test
4. Dissolution Test
 Dissolution is performed to check the percentage release from the dosage forms.
i.e. Tablet.
 Tablet breaks down into small particles which offers a greater surface area to the dissolving media.
 Disintegration test does not give assurance that particles will release drug in
solution at an appropriate rate, that’s why dissolution tests & its specifications developed for all tablet
products.
Dosage from conducted dissolution study
Immediate release tablet (conventional tablet)
1. Dissolution apparatus – Type 1 and Type 2 (USP)
2. Temperature - 37±0.5˚C
3. Time – 30 min
4. Time of interval – 5, 10, 15, 20, 25, 30.
5. Media – PH 1.2 Acidic Buffer, PH 4.5 Acetate buffer, PH 5.8 Phosphate buffer. (depending upon tablet)
6. Rpm – 75 -100 rpm
7. Volume – 900 ml

Procedure: The tablet was added into cylindrical vessel containing 1000 ml dissolution media having rpm 75 and tem.37±0.5˚C.
Dissolution of tablet was conducted 30 min, in 5 min. of interval, after 5 min 5 mL sample was removed and appropriate quantity
of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of tablet.

Sustained release tablet


1. Dissolution apparatus – Type 2 (USP)
2. Temperature - 37±0.5˚C
3. Time – 7 hrs
4. Media – PH 1.2 Acidic Buffer, PH 6.8 Phosphate buffer.
5. Rpm – 75 – 100.
6. Volume – 900 ml.

Procedure - The tablet was added into cylindrical vessel containing 1000 ml PH 1.2 Acidic media having rpm 75 for next two hours
and tem. 37±0.5˚C. Dissolution media was changes tablet was added in to PH 6.8 Phosphate buffer for next five hour for 1 hr. of
interval. After 1 hr. 5 mL sample was removed and appropriate quantity of sample take absorbance by using U.V. spectroscopy
technique and determine rate of dissolution of tablet.
Capsule
1. Dissolution apparatus – Type 2 (USP)
2. Temperature - 37±0.5˚C
3. Time – 5 hrs.
4. Media – PH 1.2 Acidic Buffer, PH 6.8 Phosphate buffer.
5. Rpm – 75 – 100.
6. Volume – 900 ml.

Procedure - The Capsule was added into cylindrical vessel containing 1000 ml PH 1.2 Acidic media having rpm 75 for next two hours and tem.
37±0.5˚C. Dissolution media was changes Capsule was added in to PH 6.8 Phosphate buffer for next three hour for 1 hr. of interval. After 1 hr. 5 mL
sample was removed and appropriate quantity of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of
Capsule.

Suppositories
5. Dissolution apparatus – Type 1 (USP)
6. Temperature - 37±0.5˚C
7. Time – 60 min
4. Time of interval – 10, 20, 30, 40, 50, 60.
5. Media – PH 7.4 Phosphate buffer.
6. Rpm – 50 – 75 rpm
7. Volume – 900 ml.

Procedure – The Suppository was added into cylindrical vessel containing 1000 ml dissolution media (PH 7.4 Phosphate buffer) having rpm 75 and
tem.37±0.5˚C. Dissolution of Suppository was conducted 60 min, in 10 min. of interval, after 10 min 5 ml sample was removed and appropriate
quantity of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of Suppositories.
Sr.no. Quantity Number of Acceptance criteria
Stage/level tablets tested

1 S1 6 Each unit is < D* + 5 percent**

2 S2 6 Average of 12 units (S1 +S2) is equal to or greater


than (> )D, and no unit is less than D - 15 percent**

3 S3 12 Average of 24 units (S1+S2+S3) is equal to or


greater than (> )D, not more than 2 units are less
than d-15 percent** and no unit is less than d-25 percent**

*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a
percentage of the labelled content.
** Percentages of the labelled content.
In Process Checks Shall Includes
Following Process Controls
 Cleanliness of the area and line clearance
 Checking of the status labels on the area and process containers.
 Equipment/instrument: Calibration, verification and checking of the status labels.
 Checking and verification of material used as Material Name, Material Code,
Control No. or A.R. No.
 Time limits at all stages of process.
 Checking of sieve/filter integrity.
 Check vendor while goods are received and it should be according to approved
vendor.
 Online review of batch record at every stage of process.
 Product attributes Like Weight, Hardness.
 Verification of yield at various stages of manufacturing process.
 Periodic check of control samples.
 Measured values obtained from the room environment like Temperature,
Humidity.

You might also like