To analyse the
physical changes in the 75mg dispersible aspirin tablets three tests were
performed to ensure the batch of tablets were appropriate for the patients
based on the British Pharmacopeia.

 

 The first test performed was the weight
uniformity test which ensures the batch of tablets is of similar weight which
would reduce the risk of the inconsistency of dosage units avoiding an
overdose/underdose taking place for patients. According to the British
Pharmacopeia, a tablet with an average mass is between 80mg and 250mg should
have a coefficient variation of less than 7.5%. When looking at the results
obtained in table 1.0- it shows that batch 2 had a coefficient variance of
0.0169%, therefore, the tablets in the multi-compartment packs were in an
acceptable range. However, the change in weight between batch 1 and batch 2
could be due to hydrolysis taking place when the tablets were placed in multi-compartment
compliance aids s in the cupboard at room temperature where they may have
absorbed moisture which would increase the moisture content in batch 2 of the
tablets, in turn, increasing the average weight overall. In a study conducted
on the stability of chronic medicines in dosage administration aids it was
shown that there was in a variation in the weight of a tablet when put in
accelerated conditions which also affected the dissolution in various storage
conditions, therefore, it was not recommended to repackage tablets in other
conditions other than what the manufacturer recommends.

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(https://ac.els-cdn.com/S1319016414000036/1-s2.0-S1319016414000036-main.pdf?_tid=b20f3fc2-fd23-11e7-9389-00000aab0f6b&acdnat=1516371729_2592536810683cf564140fc483410ae1)

 

The second test
conducted was the crushing strength test which is important as the hardness of
the tablet can affect the disintegration. When looking at the results for this
test in table 2.0 it can be seen that the batch 2 which was repackaged and
placed had a reduced mean strength of 36.2N as compared to batch 1 which was
37.5N which could be because due to the build-up of moisture in the multi-compartment
compliance aids s this would reduce the crushing strength as aspirin is
hygroscopic therefore resulting in higher levels of moisture would require less
crushing strength as compared to batch 1 due to the tablet becoming softer. If
the tablet is too hard this will increase the disintegration time which may
cause harm to the patient as the tablet can get stuck in the body resulting
perforation of an organ, shortness of breath and dysphasia of solids and
liquids.  – The crushing strength of
tablets varies as batch 2 is repackaged and place in a cupboard due to the
build-up of moisture in the multi-compartment compliance aids s this would
reduce the crushing strength as aspirin is hygroscopic which means it’s able to
absorb more moisture and due to a higher level of moisture would require less
crushing strength as compared to batch 1. If the tablet becomes too soft, this
may affect the processing of the tablet such as in processing or when applying
a coating on the tablets. According to a study on repackaged medicines, the
main risks for alteration in any medicine is moisture which may affect the
bioavailability of the drug. There may be a loss of functionality as the
increase in moisture may lead the tablets to stick together or to the
multi-compartment aid
(http://onlinelibrary.wiley.com/doi/10.1111/jphs.12176/full)

 

The disintegration
test was designed to measure the time that is required to disintegrate the
tablets into particles. When looking at the results in table 3.0- there is a
significant reduction in time taken for the tablets to disintegrate. Batch 1
took 20 seconds for the tablets to turn into particles whereas Batch 2 took 12
seconds to disintegrate. This could be because the tablets have more moisture
in them making batch 2 tablets easier to disintegrate in water as compared to
before repackaging conditions. When comparing to the British pharmacopeia the
dispersible tablets should disintegrate within 3 minutes using water at 15-25
°C whereas in the batches tested the tablets in batches disintegrated in less
than 3 minutes but the water was at 37 °C

Which was above the
standard for the British pharmacopeia
(https://www.pharmacopoeia.com/bp-2018/formulated-general/tablets.html?date=2018-01-01=dispersible+tablets.  In a study testing the disintegration of
repackaged Aspirin tablets it was found that there was an increase in water
content after leaving the repackaged aspirin tablets in a controlled room
temperature for 8 weeks due to aspirin being hygroscopic. It was found that due
to the increase there may be a risk of the hydrolysis of Aspirin to Salicylic
acid taking place which may be detrimental to the patient
https://link.springer.com/article/10.1007/s40267-017-0431-9

 

 

Titration was used
to test chemical the assay of aspirin in the aspirin 75mg dispersible tablets.

Titration is a beneficial technique to analyse kinetic measures which aid in
drug estimation titrimetry to produce a high precision result in the estimation
of degradation of product in pharmaceuticals as well as to measure the amount
of active ingredient present in each tablet
(https://www.sciencedirect.com/science/article/pii/S1878535213001056). The
titration technique was used in the experiment to determine the change in
aspirin concentration when the aspirin was repackaged into a multi-compartment
aid. As shown in table 4.0- there was a minor change in the concentration after
testing the repackaged tablets after 5 weeks of storing them in a cupboard. This does not meet BP requirements as the content of aspirin
does not fall between 95 to 105%.11  This change could be due to the increase of
moisture when the tablets were placed in the multi-compartment aids which could
be due to hydrolysis. This could result in the reduction of aspirin content which compromises patient safety.

 

Some limitations of
the experiment conducted were that there was a lack of stress tests. These
include not testing or recording the specific temperature or relative humidity.

As well as lack of running indicative tests such as high-performance liquid
chromatography which would help in identifying each component of the tablet to
identify, quantify and separate of aspirin. When running the physical and
chemical tests these should have been tested weekly as opposed to after 5 weeks
as the results could have been more precise and accurate with more data.

Another test that should have been conducted is the dissolution test as this
measures the rate of drug release from the dispersible tablets. Friability should have also been tested as this would have
checked the tendency for the tablet to crumble, chip or break after compression
especially in uncoated tablets such as a dispersible tablet.  Also, when looking at it from a patient’s
perspective- the tests should have included simulated real-life scenarios such
as tablets being handled by patients not just sitting in the cupboard which
would give a more accurate representation of how the tablets are handled when
given to patients.

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