Swami Vivekanand Sanstha’s Institute of Pharmacy (B.Pharm), Mungase, Tal. Malegaon, Dist.Nashik-423201
The usage of branded or generic medications has generated a lot of global debate in recent years. Additionally, the government of several nations is adamantly encouraging the substitution of generic medications for branded ones. A generic medication has the same active ingredient or components as its branded equivalent and has been demonstrated to have comparable therapeutic efficacy. Because generic medications do not require the extensive and expensive pre-clinical or clinical trials that are required for branded medications, their costs are significantly lower than those of branded medications. This review sheds insight on the relative efficacy of generic and branded medications additionally, an effort is made to draw attention to the expense differences between the two groups. Generic medications are not covered by a patent; branded medications are for a set period of time. All that generic medications need to do is satisfy the same bioequivalency standards as their branded equivalents. Additionally, it takes a lot longer for approved brands of pharmaceuticals to be approved than it does for approved generics. Because of the length of time it takes for branded pharmaceuticals to be approved and the expenses associated with their research, branded drugs end up being highly expensive on the market compared to generic drugs.
Cost of medicines is a major concern today. Generic drugs provide major saving opportunity in healthcare expenditure since they usually have lower price. However, physicians and patients are apprehensive regarding their quality, although they are bio-equivalents of the innovator products. The present study therefore compares the price structure and activity of the branded products and their branded-generic counterparts(1-3)
Generic drugs:-
Instead of the innovator drug, which has a brand name under which the chemical composition of the drug is sold, generic drugs refer to the chemical composition of a drug. It usually performs the same function as a proprietary drug interms of dose, potency, administration method, quality, and action. When referring to house hold goods, the term "generic" means that the item is less expensive, potentially less effective, and a replica of a name brand product. But, when it comes to generic medications, they are just as effective and of equal quality to their branded counterparts. The drug's active pharmaceutical ingredient, which is what gives the medication its therapeutic effects, is known by its generic name(4-6)
Branded drugs:-
Drugs with a trade name and patent protection are referred to as branded drugs (means that a drug can be manufactured and sold by the innovator company). A pharmaceutical company invests significant funds and resources to create, develop, and discover novel medication substances; as a result, they are granted the only right to produce and distribute the medicine for a predetermined period of time. Many people trust and are familiar with proprietary pharmaceuticals because only the innovator firm can manufacture them during the period of the patent protection(7-10)
MATERIALS AND METHODS:
Equipments used-
UV-spectrophotometer (LT-291, India), analytical balance, lab junction tablet hardness tester , disintegration tester (Model B.J-3, Shanghai Famo Machinery manufacture), dissolution test apparatus (RC-6, India), etc.
Reagents Used-
Hydrochloric acid (Blulux Laboratories Pvt. Ltd., India), Potassium Hydrogen Phosphate (Blulux Laboratories Pvt. Ltd., India), and distilled water. The dissolution medium (0.68% w/v of Potassium Hydrogen Phosphate adjusted to pH 6.8 by the addition of 0.2 M hydrochloric acid) was prepared by dissolving 6.8 gm of potassium hydrogen phosphate in sufficient distilled water to make 1000 mL solution(11-14)
Evaluation tests-
The general appearance of a tablet, its visual identity and overall "elegance" is essential for consumer acceptance, for control of lot-to-lot uniformity(15)
Appearance of a tablet involved the measurements of tablets:-
Table no. 1: General Appearance(11)
2. Uniformity of Weight
Sample tablets 20 of each brand were weighed together and the average weight was determined. Each tablet was weighed individually on an analytical balance and the percentage deviation of the tablets was calculated using the following expressions(16)
(%) deviation = [(individual weight - average weight)/average weight] × 100
Table no. 2: Uniformity of weight(11)
3. Hardness test:
Fig. No. 1: Lab Junction Hardness Tester
A hardness testing apparatus (Monsanto Hardness Test Apparatus) was used to measure the hardness of ten tablets, one at a time, from each brand. To find the compressive force that broke the tablet, the tablets were positioned between two anvils and forces were applied to the anvils(17)
Table no. 3: Hardness test(11)
4. Friability:
Fifteen tablets were chosen, meticulously dusted, and weighed for both branded and generic medications before testing. After that, the tablets were put into the friability tester's drum and turned for four minutes at a speed of 25 rpm. Tablets were reweighed and the friability percentage was computed using the following formula after 100 revolutions and dedusting.27 Per USP rules, the maximum amount of weight loss that can be achieved is 1%(18)
% Friability = [(Initial weight – Final weight)/Initial
Fig. No. 2: Friability test Apparatus
5. Disintegration test:
Using a disintegration device, tablet disintegration was measured at 37±0.5°C. In 900 millilitres of distilled water, the disintegration time of six randomly chosen tablets from each brand was measured. The amount of time required to break down the tablet and go through the mesh was noted, and the average amount of time was computed.
Fig. No. 3: Disintegration test Apparatus
Table no. 5: Disintegration test(11)
6. Assay of Metformin Hydrochloride Tablets:
Using a mortar and pestle, twenty metformin hydrochloride tablets were weighed and ground into powder. Following a 15-minute shake of a powder containing 0.1 g of metformin hydrochloride in 70 ml of distilled water, the volume was increased to 100 ml of distilled water and filtered. Ten millilitres of the filtrate were then diluted to 100 ml of distilled water, and ten millilitres of the resulting solution were diluted still further to 100 ml of distilled water to yield a nominal concentration of 10 µg/ml. Using 798 as the value of A (1%, 1 cm), the absorbance of the resultant solution was measured at its maximum at 232 nm, and the amount of metformin hydrochloride was computed.
Table no. 6: Assay of Metformin HCL(11)
7. Dissolution test:
Fig. No. 4: Dissolution test Apparatus
The USP Pharmacopoeia was followed for conducting the dissolving test. The basket was rotated at a constant speed of 100 rpm while the medium containing 900mL of phosphate buffer (pH 6.8) was kept at 37 ±0.5°C. Each brand's six tablets were chosen at random before being put to the test. After 10, 15, 20, 30, 45, and 60 minutes, the samples were removed. One hundred revolutions per minute (rpm) were applied to the paddle. At each sampling interval, 10 millilitres of samples were extracted from every dissolution test vessel. Immediately after, the same volume of a new 10 ml dissolving medium was added to keep the vessel volume constant for the duration of the analysis. The samples underwent filtering, and their absorbance was measured at a maximum of 233nm. Next, using 806 as the value of A (1%, 1 cm), the total amount of metformin hydrochloride in the medium was computed(19-20)
CONCLUSION
On both brand-name and generic metformin hydrochloride tablets, a number of quality-control tests were carried out, including assays, weight variation, friability, hardness, and disintegration time. It was discovered that the test parameters for every product that was chosen complied with official quality control standards. These goods' pharmaceutical quality hardness test results differed significantly from the specifications. There is a strong argument for manufacturers to strengthen the tablets' mechanical construction in order to significantly lower the possibility of breaking during handling and shipping by customers. It is recommended that drug regulatory bodies step up their post-market surveillance efforts, and that manufacturers also step up their post-market surveillance.
REFERENCES
Ahire Priyanka Sanjay , Aher Preeti Bapu, Tufail Dana Shakeel Ahamad, Manohar Baburao Nikam, Comparative Study of Marketed Branded and Generic Metformin Hydrochloride Tablets, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 7, 915-920. https://doi.org/10.5281/zenodo.12737933
10.5281/zenodo.12737933
