NEUTRALIZING ABILITY OF ANTACID

TABLETS:

THINGS TO DO:
1)GENERAL VIEW
2)INTRODUCTION
3)METRIALS REQUIRED
4)TESTS TO DO
5) CONSTITUENTS AND THEIR TEST
6)RESULTS
7)DISCUSSION
8)CONCLUSION
9)BIBILIOGRAPHY
GENERAL VIEW:
=> Antacids are commonly used as over - the - counter (OTC)
drugs or prescribed medications. Some antacid products may neutralize more
acid in the stomach than others. The ability of an antacid to neutralize acid is
expressed as its Acid Neutralizing Capacity (ANC).
=> This study was undertaken with the objective of assessing
the quality of different brands of antacid tablets. The assessment parameters
included the evaluation of uniformity of weight, uniformity of thickness,
crushing strength, friability, as well as the ANC (using pH and titrimetric
method), which is easy to use, accurate, reproducible, simple, and
inexpensive. The study revealed that all the brands complied with the
compendia specification for uniformity of weight and friability.
=> The acid neutralizing capacity of the brands were in the
order Brand E > Brand D > Brand C > Brand A > Brand F > Brand B > Brand G.
The average final pH of the mixture of Antacid and acid after 10 minutes is as
follows: Brand E 8.30, Brand D 7.46, Brand C 7.37, Brand A 6.67, Brand F 6.35,
Brand B 6.02 and finally Brand G 5.88.
=> It can be concluded from the study that two of the brands
(D and E) evaluated in this study could be regarded as being of highest
quality with Brand E having the highest ANC value. This study could help
prescribers to make informed choices for their patients
INTRODUCTION:
=> Antacids are commonly used worldwide as over - the - counter
(OTC) drugs or prescribed medications. Antacids are drugs that neutralize
excess gastric acids (Allen et al., 2005). They have been used as the mainstay
of treatment for peptic ulcers, gastritis, gastro oesophageal reflux disease
(GERD), and functional dyspepsia (Maton et al., 1999). Approximately 20% of
the population in the United Kingdom visits their general practitioner each
year with dyspeptic symptoms, while in Nigeria the prevalence rates range
between 70% and 90% (Moayyedi et al., 1999).
=> Gastric ulcer is normally caused by a gram negative bacterium
known as Helicobacter pylori a micro-aerophilic bacterium which means it
requires oxygen to function. Helicobacter pylori is known to inhabit various
areas of the stomach and duodenum, infection caused by it leads to chronic
inflammation in the stomach lining. Although the pathogenesis of
gastroesophageal reflux disease (GERD) is multifactorial (Scapignato, 1988)
the damaging power of the refluxed material depends primarily on gastric
acid secretion and the nature of refluxate in most of patients with GERD
[Mittal et al., 1992).
=> Some antacid products may neutralize more acid in the
stomach than others. The way to express the ability of an antacid to
neutralize acid is by determining the antacid's neutralizing capacity (ANC).
ANC measures the ability of the antacid to neutralize acids (pH of 3.5 to 4).
The US FDA requirement is that an antacid must have a neutralizing capacity
of ≥5 mEq per dose. The most effective antacids should have a high acid
neutralization capacity and rapid gastric acid neutralization qualities. Most
antacids contain magnesium hydroxide, aluminium hydroxide, calcium
carbonate, or a combination of these.
MATERIALS REQUIRED:
Seven different brands of Antacid tablet
were purchased from Pharmacies. Hydrochloric acid
(HCL), Standardized Sodium Hydroxide (NaOH) were
supplied by Pharmaceutics department, faculty of
pharmacy, Delta State University Abraka. All other
reagents used for the analysis were of analytical
grade and standard.

TESTS TO DO-
Hardness Test:
The crushing strength was determined with a tablet hardness
tester (digital tester machine (Veego digital hardness tester
Mumbai India. Model no: VDIGITAB-1). Five tablets were randomly
selected from each brand and the pressure at which each tablet
cracked, was recorded and the standard mean error was calculated.
(Indian pharmacopoeia 2007).

Friability Test:
Six tablet of each brand were weight individually and the
weight was recorded. The tablets were subjected to friabilation
at 25rpm for four minutes, the tablets were then weighed and
compared with the initial weight. Conventional compressed
tablet that lose greater than 0.5 to 1% of the weight are
considered accepted (USP, 2007).
Uniformity of Thickness :
This is the measure of the thickness of a tablet. Six tablets from
each brand were randomly selected and the thickness of each
tablet was determined using a micrometer screw gauge.
Thickness among a tablet batch should be within the range of ±
0.5 % of the standard value.

Weight Variation Test :

Acid Neutralizing Capacity Test:

pH Meter Method:
60ml of 0.1M HCL was poured into a beaker. The pH of the 0.1M
HCL was measured using a pH meter and the reading was
recorded. Three tablets from each Brand were triturated using
a mortar and pestle and transferred carefully into the beaker.
The 0.1M HCL and the antacid mixture was then Stirred for
10mins. The final pH of the 0.1M HCL and the antacid mixture
was then measured using a pH meter. Data was recorded.
Back Titration method:
One tablet from each Antacid brand was crushed using a
mortar and pestle. 0.01g was weighed out and transferred into
a 250ml Erlenmeyer flask. Exactly 50ml of 0.1M hydrochloric
acid was added to the flask and was gently swirled to dissolve
the crushed tablet as completely as possible. 2-5 drops of
bromophenol blue indicator solution was added to the flask
and a yellow color was observed which was noted, this colour
was an indication that there was excess hydrochloric acid
needed to be titrated with the standardized NaOH. The solution
is then titrated with the Standardized NaOH until the solution
just turn blue and the volume of NaOH solution required to
neutralize the excess acid was recorded. The number of moles
of HCL neutralized by each tablet was calculated and the result
expressed in milliequivalent (mEq).
DISCUSSION:
All the brands of antacid tablets used were within their shelf life as at the time of the study and all
have NAFDAC (National agency for food drug administration and control) registration number. All the
brands of antacid tablets showed acceptable uniformity of weight. The significance of the uniformity
of weight test was to ensure that the tablets were within the appropriate particle size range as well
as uniformity in mixing and die filling. The thickness of a tablet is critical to their therapeutic
effectiveness, if the thickness of tablet is monitored at regular intervals potential problems relating
to tablet weight can easily be detected at an early stage. The BP limit for tablet thickness should not
exceed ± 5% deviation. Therefore, all tablet brands passed the thickness test from the result above.
The crushing strength and friability are the measure of strength or weakness of a tablet. Friability
test was previously a non compendia test but has now been included in the United State
Pharmacopoeia (USP, 2007). Friability test is used to evaluate the tablet’s resistance to abrasion. The
compendia specification for friability is ≤ 1%. All brands met the USP specification for friability (Table
2) and this indicates that the tablets can withstand abrasion without loss of tablet integrity;
consequently the tablets can withstand the rigors of transportation and handling. Hardness test is a
non compendia test, the hardness or crushing strength assesses the ability of the tablet to withstand
handling without fracturing or chipping. Hardness can also influence friability and disintegration in
some cases. The harder the tablet the less friable and more time it takes in disintegrating. A force
range of 5 - 8 kg is the standard requirement for a satisfactory tablet (Indian Pharmacopoeia, 2007).
Hence from the mean crushing strength (Table 2) all tablet Brands failed the hardness test except
Brand D and Brand E which had hardness value of 7 kg and 7.8 kg respectively. The acid neutralizing
capacity (ANC) as revealed by Table 2 and graphically depicted by figure 2 shows that Brand E
neutralized the Hydrochloric acid the most in the order Brand E > Brand D > Brand C > Brand A >
Brand F > Brand B > Brand G but all the brands met the US FDA requirement that an antacid must
have an acid neutralizing capacity (ANC) of ≥5 mEq per dose. The average final pH of the mixture of
Brand E and HCL after 10mins was 8.30, that of Brand D was 7.46, for Brand C 7.37, for Brand A 6.67
for Brand F 6.35 for Brand B 6.03 and finally for Brand G 5.99. CONCLUSION The importance of an
antacid preparation cannot be over emphasized in the health of an ulcer patient and those with
heartburn. This study has revealed that different antacid preparations have different acid neutralizing
capacities, Brand D and Brand E showed clearly the highest ANC values, Brand E which contained
Sodium alginate, Sodium hydrogen carbon, Calcium carbonate neutralized the acid the most, but in
cases of hypertension or restricted salt intake, this product could be substituted with other brands
with equally high ANC values. This could help prescribers to make informed choices for their patients.
The titrimetric procedure used in this study is simple, inexpensive, and easy to use and could be used
in routine monitoring of the quality of Antacid tablets, especially in the absence of high technology
equipment Alalor CA et al.; East African Scholars J Med Sci; Vol-2, Iss-1 (January, 2019): 12-16 © East
African Scholars Publisher, Kenya 16 that are not easily available in most developing countries