1, 2Research Scholar, Mata Gujri College of Pharmacy, Kishanganj, Bihar- 855107
3Associate Professor, Department of Pharmaceutical Chemistry, Mata Gujri College of Pharmacy, Kishanganj, Bihar- 855107
Despite a huge amount of government funding for health care, a significant Indian population lack access to basic medications due to economic limitations. With the sky-rocketing healthcare costs, the interest in generic drugs has increased all over the world, amongst rich or poor. There is lot of myths about quality of generic products because of different types of packaging and labeling of products. This project was carried out to compare and evaluate some of the physico-chemical parameters and establish the quality of branded-generic equivalents of selected commonly used medicines manufactured by the anonymous pharmaceutical company in India. For this research purpose we procured branded and generic tablet formulations of Paracetamol and Metformin drugs from local market of Kishanganj district of Bihar state and different test evaluation like hardness, weight variation, friability, content uniformity, disintegration and dissolution test were performed at in-vitro level to achieve on a conclusion. The result of the entire quality control test concluded that the branded and generic dosage forms of Paracetamol and Metformin were as par similar apart from hardness of the branded tablets showed more pressure to break than its generic forms. No significant differences were observed in the content of drug and disintegration parameters of the branded and generic products. The differences observed huge in value regarding the cost of these two versions of drug though the manufacturing cost of the generic is less as compared to branded, while retailers get attracted to lucrative profit margin which generic hidden offers.
A generic drug or simply generic is pharmaceutical drug that contains the chemical substance which was originally protected by patents and later allowed for sale after the original drugs patents expire.[1] The active chemical substance is the same so they elicit the medical profile equivalent to patented drugs. Generic drugs enable major savings in healthcare expenditure since they are usually sold on lower price than the innovator brands as they not promoted by pharmaceutical marketers. It is a copy of branded drug whose patent has expired which has no longer exclusive rights to produce and distribute medicines. So it is imperative that generic medications be made available in India to reduce treatment costs due to the country's low accessibility and affordability.[2] The debate over name-brand and generic medications is pertinent to the globe at large as it concerns the cost and, eventually, the availability of medications to consumers everywhere. [3] The quality of the tablet is the collection of features and characteristics that contribute to its ability to meet given pharmacopeial requirements. For this study we had selected Paracetamol and Metformin medicines which are commonly used in Indian clinical practice since decades with proven efficacy and patient compatibility. These drugs are frequently traded as over the counter in most parts of the country. Paracetamol is a widely used over-the-counter analgesic and antipyretic drug and chemically, it is a 4-hydroxyacetanilide.[4] Metformin hydrochloride is an orally administered antihyperglycemic agent used in the management of non-insulin dependent (type-2) diabetes mellitus. It is chemically 3-(diaminomethylidene)-1,1-dimethylguanidine. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. [5] Since, many literature reported similarity of efficacy between branded and generic formulation, but still acceptance of generic in prescribes pen is lacking for unsung reasons. Here our efforts are devoted to the objective to erase the myths about the inferior quality of generic products and makes a comparative evaluation of Paracetamol and Metformin tablet using their branded and generic commercially available formulation. We carried out various in vitro quality control evaluation tests to head on an conclusion regarding quality of branded-generic equivalents of their branded counter parts. Different test evaluation for tablet dosage form like hardness, weight variation, friability, content uniformity, disintegration and dissolution test were performed at in-vitro level to achieve on a conclusion.
MATERIALS AND METHODS:
Paracetamol:
It is also known as Acetaminophen which is a non-opioid analgesic and antipyretic agent utilized for treating pain and fever. Numerous diseases and conditions include pain and fever as significant clinical presentation so this drug in use since many years showing huge acceptance and safety profile. [6] With these reasons paracetamol is available in almost all pharmacy counters and dispensed on prescription as well as over the counter.
Metformin Hydrochloride:
Metformin also known as Dimethyl biguanide, it is chemically a biguanide anti-hyperglycemic agent orally administrated drug commonly used to lower blood glucose concentrations in patients with type II diabetes mellitus.[7] Any patient reporting with clinical symptoms of hyperglycemia and if diagnosed to be prevailing diabetes mellitus is prescribed with metformin. The reason to select these two drugs for the study should be very clear that the common use of the drug and available every retail counter in branded and generic formulations.
MANUFACTURERS DETAILS:
Table 01: Manufacturing details of Paracetamol Branded and Generic Tablets
Table 02: Manufacturing details of Metformin Branded and Generic Tablets
Both branded and generic ready tablet formulation of Paracetamol 500mg and Metformin 500mg for the sake of convenience and mask the identity of proprietor and repeatedly using their names, were coded as BPT and GPT to represent Branded Paracetamol tablet and Generic Paracetamol tablet respectively. Similarly code was given as BMT and GMT to represent Branded Metformin tablet and Generic Metformin tablet respectively
Table 03: Code Assigned to Paracetamol and Metformin tablet.
Equipment Used:
Vernier Callipers, Monsanto Hardness Tester, Pfizer Hardness Tester, Disintegration Test Apparatus, Friability Test Apparatus (Single Drum), Electronic digital weighing balance, Digital Ultrasonicator, Digital UV-Spectrophotometer.
EXPERIMENTALWORK:
The procured tablets of Paracetamol and Metformin tablets were evaluated for Appearance, Size & Shape, Drug content, Hardness, Friability, Weight variations, Disintegration time and Dissolution rate using standard procedures as follows:
The physical (visual) appearance of tablet for aspects like surface appearance, color, odor, taste, and or any identifying marks on each tablet was observed.[8]
The thickness and diameter of tablet was determined using Sliding Vernier caliper. [9]
Weight variation test is performed to check the manufactured tablets uniformity of weight. For this purpose 20 tablets were weighed individually from all set tablets using digital electronic balance and average weight was calculated. An allowance of 5?viation of weight of average weight as per Indian Pharmacopoeia was obtained and upper limit and lower limit of allowable deviation was fixed. [10]
Roche Friabilator instrument was designed to evaluate the friability of tablet as it relates to hardness or the strength to withstand wear are tear during handling, transportation and packing in its course of journey from manufacturer to consumer. 10 tablets are weighed accurately in digital balance are placed in the drum of Roche Friabilator. The Friabilator is allowed to rotate for 4 minutes (100 revolutions). The good intact tablets are weighed again. The loss in tablet weight was calculated in percent weight loss, which should not be more 1%.[11]
Tablet hardness test is a laboratory technique used by many of the tablet manufacturers to determine the breaking point and structural integrity of a tablet.[12] The tablet to be evaluated is placed on the lower plunger, and the upper plunger of Monsanto Hardness tester and upper plunge is lowered onto it by screwing the plunge. In the case of Pfizer hardness tester tablet is compresses between a holding anvil and a piston connected to a force-reading gauge when its plier-like handles are gripped. The plier is compressed to grip the tablet by applied force.
Uniformity of drug content is a pharmaceutical assay for the quality control count of active drug substance in the formulation.[13] A powder containing 0.1 g of paracetamol and 0.10 g of metformin was subject to assay procedure and content of drug was recorded as percent purity using Ultraviolet-Visible spectroscopy.
Unit Disintegration test apparatus employed to determine the disintegration time of all tablets by using water as test fluid at 37±1°C.[14]
Comparative evaluation of cost between branded and generic tablets of both the drugs was evaluated and cost chart is prepared. Price-to-patient (MRP) for two branded medicines and their branded-generics version compared.
RESULT and DISCUSSION:
All the coded tablet were evaluated using procedure mentioned in the earlier section following IP and USP, the observation and resulted obtained is interpolated as below:
Table 04: Appearance of Tablets under evaluation.
Size:
Table 05: Diameter of evaluated tabled in cm.
Table 08: Thickness (Width) in cm. of Tablets under evaluation.
Weight variation test:
Weight variation test found that no tablets from each category deviated from the upper limit or lower limit range
Table 06: Weight variation test for branded and generic tablets shows no single tablet deviates from the set range.
Friability Test:
The Roche Friabilator was used and found that all types of showed loss less that 1% percent which is compatible by document stating that it should be less that 1%
Table 7: Weight Loss in ?ter conducting Friability test.
The hardness of the tablet was determined using Monsanto and Pfizer hardness tester and expressed in kg/cm2.
Table 8: Hardness Test using Monsanto Hardness Tester.
Table 9: Hardness Test using Pfizer Hardness Tester.
Drug Content Uniformity Test:
Drug content assay or content uniformity is determined by U.V. Spectrophotometer at ?max. 257nm for paracetamol and 232nm for metformin.
Table 10: Percentage Drug Content.
Disintegration test:
Six tablets from each brand were tested and a mean disintegration time was calculated.
Table 11: Disintegration Time evaluated in minute.
Market Cost Evaluation:
Price-to-patient (MRP) for two branded medicines and their branded-generics version compared.
Table 12: Paracetamol Tablet Market cost.
Table 13: Metformin Tablet Market Cost Evaluation.
CONCLUSION
The in vitro evaluation of branded and generic dosage forms of Paracetamol and Metformin was at par similar, apart from hardness test as the branded tablets showed more pressure to break than its generic forms. No significant difference was observed in the content of active drug and disintegration parameters of the branded and generic products. This establishes the Quality of generics is same as for their branded version. None of the branded or generic tablets deviated from give allowance range in weight variation test. The general appearance was white with flat surface and does produce any odour. No significant difference was seen in thickness and diameter amongst the similar category of tablet. The loss of tablet after friability test was mere 0.9% which is less that 1% that satisfy the test norms. The differences observed huge in value regarding the cost of these two version of drug though the manufacturing cost of the generic is less as compared to branded but it has lucrative profit margin to its sales. Many generic are also sold in lesser prices, thus it is necessity to encouraging the use of less expensive generic substitutes rather than brand medications. The recommendation to be mention here is to modify the drug price policy, regulate the mark-ups in generic supply chain and widely publicize the quality testing of generics for awareness of all stakeholders.
ACKNOWLEDGMENTS
We acknowledge the recognition to the Principal of Mata Gujri College of Pharmacy, Kishanganj for his support in conducting this research project. This work was emotionally supported by the family members and professionally supported by college laboratory Staff. Finally, much thankful to all whom, we could not mention here for compiling process.
CONFLICT OF INTEREST
The authors declare no conflict of interest, financial or otherwise.
CONSENT FOR PUBLICATION:
The authors declare that the content submitted here in this journal is not submitted for consideration for publication or no published elsewhere.
REFERENCES
Roushan Kumar Singh , Suman Kumar Sinha , Anil Parasnath Sao , In Vitro Comparative Evaluation Of Paracetamol And Metformin Branded And Generic Tablets, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 9, 576-583. https://doi.org/10.5281/zenodo.13749353
10.5281/zenodo.13749353
