I am herewith enclosing the manuscript entitled “hemoglobin a1c: biomarker for diabetes prediction” for publication
JOURNAL OF DRUG DELIVERY RESEARCH ISSN 2319-1074 Research Article STUDY OF ALTERED DISINTEGRATION RATES OF PAIN RELIEF DRUGS IN DIFFERENT BEVERAGES Sreelesh Brinda 1*, Vaze Varsha 1, Rakha Pankaj 3, Dhingra Gitika Arora 1, Nagpal Manju2, Gadge M. S. 1
1. NCRD’S Sterling Institute of Pharmacy, Sector- 19 A, Nerul, Navi Mumbai
2. Chitkara School of Pharmaceutical Sciences, Chitkara University, Solan (HP)
3. PDM School of Pharmacy, Karsindhu, Safdon, Jind.
ABSTRACT Variable drug release from the solid dosage forms has been an important cause of bioavailability problems. The two main processes by which they release drugs are disintegration and dissolution. In the present study the disintegration time of three immediate release dosage pain –relief tablets, Mefenamic acid-Drotaverine HCl (250mg/80mg), Mefenamic acid- Dicyclomine HCl (250mg/10-mg tablets) , Ibuprofen-Paracetamol (400mg/325mg) tablets indifferent beverages were compared with water. The beverages chosen were 6% and 3.5% Milk, Soft drink, Butter milk and Fruit juice. The test was carried out using USP disintegration test apparatus. The results showed that the disintegration time was highest in 6% milk then in 3.5% milk, subsequently followed by fruit juices and butter milk .The disintegration was the least in the soft drink. The addition of the USP disc to stimulate food weight on disintegration of IR tablets revealed that food weight is not an important parameter in such a dosage form. These were all in comparison to its breakup in water. From the above study it can be concluded that there is a variation in the disintegration time of the pain relief tablets in different beverages. The highest variation was found when milk was the beverage. The patients on these medications should be advised against consuming them with beverages slowing their disintegration and in turn affecting their bioavailability. KEYWORDS : Disintegration test, food effect, pain relief IR tablets. INTRODUCTION
administration, has long been a problem.
therapeutic failure or drug toxicity, the
'art of bespoke prescribing’ remains a
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major goal of clinical pharmacology [2].
area to the fluid. Hence, in vitro
In the past variation in the composition,
disintegration test is an official test. It is
occasionally in intestinal medium. In the
prescribed to perform this test with the
aim to test batch-to-batch reproducibility
of tablets. But if the drugs are ingested
with different beverages, it will affect
category of drugs, patients are counseled
to take medication with fluids other than
water like in pain-relief medications; to
thereafter be absorbed into the systemic
In the study of disintegration of TriCor
'bioavailability' is used to describe the
both 'acutely', if a drug is taken with a
meal, and 'chronically', where regularly
absorption of the drug, which is affected
gastrointestinal fluids and permeability
is greatly influenced by disintegration of
such as milk, butter milk, fruit juice, and
tablet due to exposure of limited surface
Volume 1 Issue 2: 2012 www.earthjournals.org JOURNAL OF DRUG DELIVERY RESEARCH ISSN 2319-1074
disintegration apparatus and loaded into
a one-liter, low-form glass beaker filled
Indian families. Amul Masti (buttermilk)
maintained at 37.0 ± 1.0 °C throughout
the entire test period. The apparatus was
calibrated based on the guideline of USP MATERIALS AND METHODS 31–NF 27 to ensure that the basket
Materials
Three IR pain-relief tablets were chosen
disintegration parameter, the tested pain
348.7 ± 3.8 mg, n = 3), Mefenamic acid-
was then placed flat on top of the tablet.
tablets (Meftal Spas by Blue Cross Labs,
2012; total tablet weight 300.6 ± 2.9 mg,
No.- 029136, Exp. July 2012; total tablet
weight 920.5 ± 2.3 mg, n = 30) were
Statistical Analysis
independent t-test and one-way ANOVA
were considered significant at p < 0.05
RESULTS AND DISCUSSION Volume 1 Issue 2: 2012 www.earthjournals.org JOURNAL OF DRUG DELIVERY RESEARCH ISSN 2319-1074
during lunch. The disintegration in this
beverages. The control used was distilled
for as compared to 5.2 ± 0.17 min (n=6),
The three drug candidates chosen for the
of 2.8±0.6 min (n=6) in butter milk and
carbon dioxide. It may be suggested that
as high as 20.6±0.9 min (n=6) in water.
Again a vast difference of nearly 18 min.
earlier studies it has been reported that
disintegration. Statistical results also
indicated that disintegration of all three
the results obtained in water suggesting
Dicyclomine tablet which was 0.4 ± 0.10
(n=6) in water. The duration required for
the DT difference in juice and water was
disintegrate in the soft drink was 2.08 ±
statistically significant), but 22.6±0.12
20.6 ± 0.9 min (n=6) in water. It showed
medicines. It is psychological notion of
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gastric distress. The disintegration was
carried in milk with fat content of 3.5%
media, may be atttributed to the lipidic
nature of milk. It was also observed that
respectively. The DT results obtained in
the food weight effect exerted on a tablet
tablet to break down. The disintegration
ingested after meal, the data indicate that
significant result of faster disintegration
respectively as compared to a very rapid
disintegration of 0.8 ± 0.23min (n=6) in
tablets revealed that food weight is not
Immediate release tablets are formulated
CONCLUSION
their constituent granules and then into
different beverages on the disintegration
Disintegrants, an important excipient of
of IR pain relief medications. The results
the tablet to induce breakup of the tablet
fluid. It can be further noted that most of
(sprite), buttermilk (amul masti) , fruit
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It is also suggested that instead of using
only a straight beverage as disintegration
present in the stomach. Other factors like
especially pain relief medications, with
milk to decrease the potential for gastric
irritation. Since an IR pain medication is
will affect the disintegration of tablet in
Table 1. Disintegration times of (A) Mefenamic acid- Dtrotaverine HCl , (B) Mefenamic acid- Dicyclomine, and (C) Ibuprofen-Paracetamol tablets in 800 ml of test beverages. Mefenamic
6.5% milk 105 min ± 0.8 mina (n=6) 52.2 min ± 0.54 mina 9.9 min ± 1.08 mina
3.5% milk 90.8 min ± 0.2 mina (n=6) 39.6 min ± 0.46 mina 5.5 min ± 0.4 mina
10.3 min ± 0.17 mina 22.6 min ± 0.12 mina 5.4 min ± 0.11 mina
2.08 min ± 0.6 mina (n=6) 2.6 min ± 0.53 mina 0.4 min ± 0.10 mina
8.9 min ± 0.2 mina (n=6) 2.8 min ± 0.6 mina 1.3 min ± 0.53 mina
5.2 min ± 0.17 mina (n=6) 20.6 min ± 0.9 mina 0.8 min ± 0.23 mina
(Control) a indicates that the result obtained is significant at 95% confidence interval. b indicates that the result obtained is not significant at 95% confidence interval.
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Table 2: Disintegration times of (A) Mefenamic acid- Dtrotaverine HCl , (B) Mefenamic acid- Dicyclomine, and (C) Ibuprofen-Paracetamol tablets in 800 ml of test beverages using a 3.05-g USP disk to simulate food-weight effect . Mefenamic
51.9 min ± 0.54 mina 9.8 min ± 1.1 mina (n=6)
3.5% milk 83.8 min ± 0.2 mina (n=6) 37.6 min ± 0.46 mina 5.5 min ± 0.4 mina
21.8 min ± 0.12 mina 5.4 min ± 0.11 mina
2.08 min ± 0.6 mina (n=6) 1.5 min ± 0.53 mina 0.4 min ± 0.10 mina
8.1 min ± 0.2 mina (n=6) 2.8 min ± 0.6 mina 1.3 min ± 0.53 mina
3.1 min ± 1.5 mina (n=6) 16.6 min ± 0.4 mina 0.8 min ± 0.23 mina
(Control)
a indicates that the result obtained is significant at 95% confidence interval. b indicates that the result obtained is not significant at 95% confidence interval. REFERNCES: Volume 1 Issue 2: 2012 www.earthjournals.org JOURNAL OF DRUG DELIVERY RESEARCH ISSN 2319-1074
Pharmacopeia and National Formulary USP 31–NF 26; The United States Pharmacopeial Convention, Inc.: Rockville MD, 2008: 266.
Neil, R. Tablets. In: L. Lachman, H. A. Lieberman , and J. L. Kanig (eds.), The Theory and Practice of Industrial Pharmacy. 306, 1991.
disintegration and drug dissolution in viscous media: paracetamol IR tabl 355(1-2); 2008: 93-9.
Dickinson, P.A. An investigation of the disintegration of tablets in biorelevant media. Int J Pharm .2005; 290: 121-12.
Tablets and Compactation. Pharmaceutics: The Design and Manufacture of Medicines.
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Helping you make the most of your drug coverageYour group benefit plan covers drugs listed on the National Formulary. Although it covers approximately 85% of the mostfrequently prescribed drugs in Canada, you may find yourself with a prescription for a drug that isn’t on the list. This isimportant to understand because non-formulary drugs are either covered at a lower percentage, or not covered