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ORIGINAL ARTICLE
Year : 2012  |  Volume : 2  |  Issue : 1  |  Page : 40-44

Evaluation of pharmaceutical equivalents of different brands of ranitidine tablets from multinational brands in Oman


Pharmacy Department, Oman Medical College, Azaiba, Muscat, Sultanate of Oman

Date of Submission17-Sep-2011
Date of Acceptance01-Oct-2011
Date of Web Publication23-Feb-2012

Correspondence Address:
A R Mullaicharam
Pharmacy Department, Oman Medical College, Azaiba, Muscat
Sultanate of Oman
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2231-0738.93133

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   Abstract 

Aim : The aim of the present study was to evaluate the pharmaceutical equivalent of different brands of Ranitide Hydrochloride tablets. Materials and Methods : Three different brands of ranitidine hydrochloride 150 mg tablets have been evaluated using some quality control test of weight variation, friability, hardness and disintegration with aim to assess whether these 3 brands are pharmaceutically equivalent or not. The results obtained have been compared with USP standards. Result : The results indicated that all the tablets in the three brands have met the requirements of the quality control test (weight variation, friability, hardness and disintegration) according to the USP which indicated that they are pharmaceutically equivalent.

Keywords: Pharmaceutical equivalent, ranitide HCl, tablets


How to cite this article:
Mullaicharam A R, Jehangir Ahmed JA, Halligudi N. Evaluation of pharmaceutical equivalents of different brands of ranitidine tablets from multinational brands in Oman. Int J Nutr Pharmacol Neurol Dis 2012;2:40-4

How to cite this URL:
Mullaicharam A R, Jehangir Ahmed JA, Halligudi N. Evaluation of pharmaceutical equivalents of different brands of ranitidine tablets from multinational brands in Oman. Int J Nutr Pharmacol Neurol Dis [serial online] 2012 [cited 2019 Dec 13];2:40-4. Available from: http://www.ijnpnd.com/text.asp?2012/2/1/40/93133


   Introduction Top


Ensuring uniformity in standards of quality, efficacy and safety of pharmaceutical products is the fundamental responsibility of Food and Drug Adminstration (FDA). Reasonable assurance has to be provided that various products, containing same active ingredients, marketed by different licensees, are clinically equivalent.

Pharmaceutical equivalents is when the drug products contain the same active ingredients, are of the same dosage form, route of administration and are identical in strength or concentration. [1]

Bioavailability is the rate and extent to which a substance or its active moiety is delivered from a pharmaceutical form and becomes available in the general circulation. [1]

Bioequivalence studies are useful in comparing the bioavailability of drug from various drug products. Once drug products are demonstrated to be bioequivalent, then efficacy of these drug products is assumed to be similar. Bioequivalent drug products should have the same systematic drug bioavailability and therefore the same predictable drug response. [1]

According to this each drug before introducing to the market need to undergo bioequivalence requirements to have the approval from FDA.

This study was conducted to evaluate the pharmaceutical equivalent of different brands of Ranitide HCl tablets. Ranitide HCl is H 2 receptor antagonist. [2],[3] This drug inhibit stomach acid production. It is used as antiulcer drug. [4]

Different brands were tested and compared with the pure form of Ranitide HCl to determine if they had the same bioavailability and bioequivalence. The various brands of Ranitide HCl that were available in Oman were evaluated and tested under standards criteria according to USP. Tests included weight variation, thickness, hardness, friability, and disintegration. All brands contained the same amount of Ranitide HCl. Quality control results for the different brands of tablets were obtained and evaluated.


   Materials and Methods Top


  1. Ranitide HCl (150 mg) film coated tablets from the following three different brands
    • Zantac (Galaxo welcome)
    • Histac (RaNBAXY)
    • Ranid (Tabuk Pharmaceutical Manufacturing Co. Saudi Arabia)


Apparatus and equipments:

  1. Analytical Balance
  2. Rolex Tablet Hardness(Belstone, Hi-Tech International)
  3. Friability tester(Bellstone, Hi-Tech International)
  4. Disintegration Apparatus(Belstone, Hi-Tech International)


Quality control tests [5],[6]

Weight variation test


The 10 tablets of Ranitide HCl were dusted and weighed individually using the analytical balance. The average weight and standard deviation were calculated. The procedure was repeated for three times for each brand of Ranitide HCl tablets. [5],[6]

Friability test

The 10 tablets were dusted and weighed on the analytical balance. The tablets were placed in the section 1 of the drum of the friability tester [Figure 1] and rotated 100 times for 4 minutes. The tablets were re-dusted, re-weighed and any loss in weight was noted. The procedure was repeated for three times for each brand of Ranitide HCl tablets.
Figure 1: Friability test apparatus

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Hardness test

The 10 tablets were individually placed between the platens of the hardness tester [Figure 2] using the forceps. The test button was pushed and the visual reading of instrument of tablet hardness test was noticed. The procedure was repeated for three times for each brand of Ranitide HCl tablets.
Figure 2: Hardness tester

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Disintegration test

A 900 ml beaker was filled with water and maintained at 37°C.

From each brand six tablets were placed in to the basket-rack assembly and connected to the disintegration apparatus [Figure 3]. The basket was immersed in water.
Figure 3: Disintegration test apparatus

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The apparatus and the timer were started simultaneously and the time required for the last tablet to disintegrate was recorded. The procedure was repeated for three times for each brand of Ranitide HCl tablets [Table 1].
Table 1: Three different brands of ranitide HCl (150 mg) film coated tablets

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   Results Top


The results of weight variation (uniformity), hardness test, friability, and disintegration were shown below.

  • Weight variation
  • Friability test
  • Hardness test
  • Disintegration test



   Discussion Top


Uniformity of weight (weight variation) disintegration, are compendia standards to assess the quality of tablets while hardness and friability are referred to as non compendia standards although friability is now included in the USP. [6]

Weight variation

The [Table 2] and [Figure 4], indicated the weight variation values of zantac, Histac, ranid, which showed that among these 3 brands, Histac has the highest value of mean, compared with other 2 brands.
Figure 4: Weight variation of 3 different brands of Ranitidine HCl tablets with strength of 150 mg

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Table 2: Weight variation values with mean and standard deviation for each 3 different brands of ranitidine HCl with strength of 150 mg. N=3

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The requirements are met with weight variation according to USP that is, out of all the brands the weight of not more than 2 tablets differs from the average weight by more than 7.5%.

Difference in weight between these 3 brands (Zantac, Histac, Ranid) of Ranitidine tablets is due to the following factors:

  1. Non-uniform amount of an active ingredients
  2. Pressure difference during compression process
  3. Uniformity of weight does serve as a pointer to good manufacturing practice (GMP) as well as amount of the active pharmaceutical ingredient (API) ranitidine hydrochloride contained in the formulation.


Friability

The [Table 3] and [Figure 5] (% weight loss for Zantac, Histac, ranid) showed that Histac has the highest % weight loss and ranid has the lowest % weight loss, when compared to Zantac.
Figure 5: Percentage weight loss for each 3 different brands of ranitidine HCl with strength of 150 mg after friability test

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Table 3: Percentage weight loss for each 3 different brands of Ranitidine HCl tablets with strength of 150 mg after friability test. N=3

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All the 3 brands have less than 1% of weight loss, which indicated that, these brands were, met the USP requirements. A maximum % weight loss not more than 1% is considered as acceptable values as per the USP.

Weight loss determines how well the tablets will stand up to packaging; shipping, and transport. Friability test is used to evaluate the tablets resistance to abrasion.

Hardness

The [Table 4] and [Figure 6] (Hardness (kg) values of Zantac, Histac, Ranid) indicated that Zantac needs the highest value of force to break the tablet (16.6 kg) when compared to other two brands.
Figure 6: Hardness (kg) for 3 different brands HCl tablets with strength of 150 mg

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Table 4: The values of hardness (Kg) with mean and standard deviation for 3 different brands of ranitidine HCl tablets with strength of 150 mg N=3

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The values of hardness for all the three brands are met with USP requirements. A force of about 4-6 kg is considered the minimum requirement for satisfactory tablet.

The hardness or crushing strength assesses the ability of tablets to withstand handling without fracturing or chipping. It is also influence friability and disintegration. The greater the pressure applied the harder the tablets.

Disintegration

The [Table 5] and [Figure 7] (Disintegration values of Zantac, Histac, Ranid) indicated that Histac and Ranid has less disintegration time when compared with the disintegration time of Zantac.
Figure 7: Disintegration of 3 different brands of ranitidine HCl tablets with strength of 150 mg

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Table 5: The values disintegration with mean and standard deviation for different 3 brands of ranitidine HCl tablets with strength of 150 mg. N=3

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The disintegration time for all the 3 brands met with USP requirements. As per the USP specification, uncoated and film coated tablets should disintegrate within 30 min.


   Conclusion Top


Quality control tests of drugs are a set of studies and experiments undertaken during production and occasionally ought to be undertaken post-production by regulatory agencies and researchers. Three different brands of ranitidine hydrochloride 150 mg tablets have been evaluated using some quality control test of weight variation, friability, hardness and disintegration with aim to assess whether these 3 brands are pharmaceutically equivalent or not. The results obtained have been compared with USP standards.

The results indicated that all the tablets in the three brands have met the requirements of the quality control test (weight variation, friability, hardness and disintegration) according to the USP which indicated that they are pharmaceutically equivalent. Although, there were slight differences between the brands due to the various manufacturing process, all the brands have met the requirements for quality control tests.

A generic drug of Ranitidine HCl (generic drugs, short: Generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. [7] The potential nanotechnology in the field of pharmaceutical biotechnology will positively affect medical and pharmaceutical science in all areas. [8] Biotechnology allows bespoke production of biopharmaceuticals and biotechnological drugs; however, many of them require special formulation technologies to overcome drug-associated problems. [9]

This study is used to conclude that among these five brands of Ranitidine Hydrochloride tablet any one of the brand may used as alternative of other brands, in the situation of nil stock of other four brands in pharmacy.

 
   References Top

1."Food and Drug Administration Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations". Available from: http://fitoica.com/Biblioteca/Libros/Farmacologia/F016.pdf. [Last accessed on 2011 July 09].  Back to cited text no. 1
    
2.British Medical Association: New Guide to Medicine and Drugs (Seventh edition). Chief Medical Editor; Professor John A. Henry MB FRCP.2007.  Back to cited text no. 2
    
3.British National Formulary. Royal Pharmaceutical Society of Great Britin, 1 Lambeth High Street, London SE1 7JN; 2008.  Back to cited text no. 3
    
4.Available from: http://dailymed.nlm.nih.gov/dailymed/fdaDrugXsl.cfm?id=2398. [Last accessed on 2011 July 09].  Back to cited text no. 4
    
5.US Pharmacopeia National Formulary USP. 12601 Twinbrook Parkway, Rockville, MD 20852: United State Pharmacopeia Convention. Inc; 2004.  Back to cited text no. 5
    
6.The Theory and Practice of Industerial Pharmacy. Special Indian ed. In: Leon L, Ph.D. Lacham Consultant Services, Inc. Herbert A. Liberman, Ph.D. H. H Lieberman Associates, Inc. Consultant Services. New Jersey: Livingstone; 2009.  Back to cited text no. 6
    
7."Generic Drug": http://en.wikipedia.org/wiki/Generic_drug. [Last accessed on 2011 July 09].  Back to cited text no. 7
    
8.Mullaicharam AR. Nanoparticles in drug delivery system. Int J Nutr Pharmacol Neurol Dis 2011;1:103-9.  Back to cited text no. 8
  Medknow Journal  
9.Saini R, Saini S, Sugandha RS. Biotechnology: The novel drug delivery system. Int J Nutr Pharmacol Neurol Dis 2011;1:82-3.  Back to cited text no. 9
  Medknow Journal  


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]


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