INTRODUCTION:

Diabetes mellitus is a chronic metabolic condition marked by persistently high blood sugar levels brought on by deficiencies in either the action or secretion of insulin, or both. Type 1 and Type 2 diabetes are the two main forms of the disease. While Type 2 diabetes, which accounts for 90–95% of cases of diabetes, is predominantly characterized by insulin resistance and relative insulin shortage, Type 1 diabetes is an autoimmune disease that causes the death of the pancreatic beta cells that produce insulin¹.

Globally, diabetes is becoming more and more common. The World Health Organization (WHO) estimates that diabetes directly contributed to 1.5 million deaths in 2019². In 2021, 537 million individuals between the ages of 20 and 79 had diabetes, according to the International Diabetes Federation (IDF); by 2030, that figure is expected to rise to 643 million, and by 2045, it will reach 783 million³. Diabetes is a major global health concern, contributing to around 12.2% of adult fatalities⁴.

Diabetes is a serious public health issue in India. India, which is frequently called the "diabetes capital of the world," 77 million persons are expected to develop diabetes in 2019; by 2045, that number is expected to rise to 134 million⁵. Because of its consequences, which include kidney failure, neuropathy, and cardiovascular disorders, the disease has a high risk of morbidity and mortality^6,7.

One of the drugs most frequently recommended to treat Type 2 diabetes is metformin. Its cost-efficiency, safety profile, and effectiveness make it a popular choice⁸. There are many different brands of metformin available in India, which reflects how widely used and accepted it is^9,10. In addition to numerous others, some of the well-known brands of metformin that are sold in India are Brands A, B, C, D, and E. Strict quality control is required due to the variety of brands to guarantee that every product satisfies the required therapeutic criteriaOne of the drugs most frequently recommended to treat Type 2 diabetes is metformin^11,12. Its cost-efficiency, safety profile, and effectiveness make it a popular choice. There are many different brands of metformin available in India, which reflects how widely used and accepted it is. In addition to numerous others, some of the well-known brands of metformin that are sold in India are Brands A, B, C, D, and E. Strict quality control is required due to the variety of brands to guarantee that every product satisfies the required therapeutic criteria^13,14.

Metformin hydrochloride, commonly referred to as 1,1-dimethylbiguanide hydrochloride, is an oral antihyperglycemic medication that is a member of the biguanide class¹⁵. By inhibiting hepatic gluconeogenesis, enhancing peripheral glucose absorption, and increasing insulin sensitivity, it primarily reduces blood glucose levels¹⁶. The molecular formula of Metformin is C₄H₁₁N₅·HCl, and its structural formula is represented as:

Metformin is well known for helping persons with Type 2 diabetes control their weight and improve cardiovascular outcomes, and it has been thoroughly studied. Many patients choose it because of the reduced risk of hypoglycemia that comes with using it¹⁷. Because of its effect on cellular metabolism, metformin has been investigated for possible advantages in diseases including polycystic ovarian syndrome (PCOS) and as an anti-aging agent in addition to its core use in diabetes¹⁸.

Comparing the in-vitro performance of five different brands of metformin hydrochloride tablets available in Satara, Maharashtra, is the primary goal of this study. Brands A, B, C, D, and E are the brands that are part of this study. To make sure these brands satisfy the required pharmacopeial criteria and are therapeutically interchangeable, the study aims to evaluate and compare their physicochemical characteristics, dissolving profiles, and general quality. Maintaining the effectiveness and safety of metformin as a therapy option for diabetic patients in the area depends on this assessment.

MATERIALS AND METHODS:

Sample Collection:

For this investigation, five distinct brands of 500 mg doses of metformin hydrochloride tablets were acquired from separate pharmacies in Satara, Maharashtra. Among the brands that were chosen are A, B, C, D, and E.

Reference Sample:

Novartis Pharma's reference sample of metformin hydrochloride served as the benchmark for the comparison study. In order to guarantee the precision and dependability of the assessment procedures, this reference sample was given as a gift. Throughout the investigation, freshly distilled water was used, and all of the reagents were of analytical quality.

Instruments:

The physicochemical properties of the metformin hydrochloride tablets were assessed using a variety of analytical techniques. The instruments and related models used in this study are listed below:

· UV Spectrophotometer: Shimadzu UV-1900

· Friabilator: Roche Friabilator (Model FR 2000)

· Hardness Tester: Monsanto Hardness Tester (Model MH-1)

· Disintegration Tester: Electrolab Disintegration Tester (Model ED-2L)

· Dissolution Apparatus: USP Type II (Paddle) Dissolution Apparatus, Electrolab (Model TDT-08L)

· Analytical Balance: Sartorius Analytical Balance (Model AY123)

· pH Meter: Mettler Toledo pH Meter (Model SevenCompact S220)

Methods:

The physicochemical characteristics of the metformin hydrochloride tablets were assessed using the following techniques:

Uniformity of Weight:

The Sartorius Model AY123 analytical balance was used to weigh twenty tablets of each brand separately. The mean weight and standard deviation were calculated to assess uniformity¹⁹.

Hardness Test:

The Monsanto Hardness Tester (Model MH-1) was used to measure the hardness of ten pills from each brand. The mean hardness and standard deviation were computed.

Friability Test:

The Roche Friabilator (Model FR 2000) was used to weigh ten tablets from each brand. For four minutes, the friabilator was run at 25rpm (100rpm). The percentage of friability was then calculated by weighing the tablets one again.

Disintegration Test:

The Electrolab Disintegration Tester (Model ED-2L) was used to test the disintegration of six tablets from each brand. It was noted how long it took for each tablet to fully dissolve²⁰.

Dissolution Test:

The USP Type II (Paddle) Dissolution Apparatus, Electrolab (Model TDT-08L), was used to conduct the dissolution investigation. The dissolving medium was 900 milliliters of phosphate buffer (pH 6.8) that was maintained at 37±0.5°C. A paddle speed of 75rpm was used. At specified intervals (5, 10, 15, 20, 30, 45, and 60 minutes), samples (1mL) were taken out and replaced with an equivalent volume of brand-new dissolving medium. After filtering the samples, the Shimadzu UV-1900 spectrophotometer was used to detect the absorbance at a wavelength of 232nm. It was determined the cumulative percentage of drugs discharged²¹.

Assay of Metformin Hydrochloride Tablets:

Using UV spectrophotometry, the metformin hydrochloride tablets were tested. We prepared a standard stock solution of 100μg/mL of metformin hydrochloride in phosphate buffer (pH 6.8). serial dilutions from 1 μg/mL to 10μg/mL were carried out to produce a standard calibration curve. These dilutions were tested for absorbance at 232nm using a Shimadzu UV 1900 spectrophotometer. The calibration curve was then created, with the x-axis standing for concentration and the y-axis for absorbance.

Figure 1. Standard calibration curve of metformin

To reach a concentration within the calibration range, tablet samples from each brand were precisely weighed, ground into a powder, and dissolved in phosphate buffer (pH 6.8). These solutions' absorbance was measured at 232 nm, and the calibration curve was used to calculate the quantity of metformin present. This technique guarantees accurate active ingredient measurement, preserving dose precision and quality control across various brands.

Statistical Analysis:

The data was expressed using the standard deviation (SD) ±mean. To ascertain the importance of the variations between the brands, a comparative study of the outcomes obtained for each brand was carried out using the proper statistical techniques. Verifying the therapeutic interchangeability of the various brands of metformin hydrochloride tablets accessible in Satara, Maharashtra, the strict protocols guarantee a thorough assessment of the tablets' quality and functionality.

To comprehend the mechanisms of Metformin's release from the tablets, the dissolving data was examined using a variety of kinetic models. The models listed below were used.

1. Zero Order Kinetics:

· Describes a procedure in which the rate at which a medication is released is not affected by its concentration.

Equation: Q_t= Q₀+ k_0t

· Where k0 is the zero-order release constant, Q_t is the amount of medication dissolved in time t, and Q₀ is the starting medication concentration in solution, which is typically 0.

2. First Order Kinetics:

· It explains the process by which the drug's concentration determines how quickly it is released.

Equation: log Q_{t =}log Q₀ + k₁t/2.303

Qt is the amount of drug dissolved in time t, Q₀ is the starting amount of medication in solution, and k1 is the first-order release constant.

3. Higuchi Model:

· Explains how Fick's law governs the diffusion process of medication release.

Equation: Q_t= k_H√t

Where kH is the Higuchi dissolving constant and Qt is the quantity of medication released in time t.

4. Korsmeyer-Peppas Model:

· Describes drug release from a polymeric system.

Equation: Q_t/Q_∞ = k_ktⁿ

where k_k is the Korsmeyer-Peppas rate constant, n is the release exponent that indicates the drug release mechanism, and Qt/Q∞ is the fraction of drug released at time t.

5. Hixson-Crowell Cube Root Law:

· Explains the release from systems where the diameter and surface area of the particles or tablets fluctuate.

Equation: Q_t^1/3 = Q₀^1/3 – k_HCt

Where k_HC is the Hixson-Crowell rate constant, Q_t is the amount of drug released in time t, and Q₀ is the initial amount of medication.

These kinetic models can be used to examine the dissolution patterns of several brands of metformin hydrochloride tablets and aid in the understanding of drug release mechanisms²².

RESULTS AND DISCUSSION:

Physicochemical Properties:

The physicochemical properties of Metformin hydrochloride tablets from different brands were evaluated. The details are presented in the table-1.

Important information on the quality and performance of the 500mg metformin hydrochloride tablets from Brands A, B, C, D, and E was uncovered by a thorough analysis of their physicochemical characteristics and dissolution profiles.

The tablets' thickness ranged from 0.35cm (Brand D) to 0.48 cm (Brand E), according to the physicochemical examination, which is summed up in Table 1. All brands showed satisfactory weight uniformity, guaranteeing constant dosage distribution. From 5.60±0.13kg/cm² in Brand D and Brand E to 7.98±0.18kg/cm² in Brand C, the hardness varied greatly, suggesting that Brand C had a robust formulation while the other brands had enough hardness for patient handling and mechanical stability.

All of the brands' friability findings were well within acceptable bounds; Brand A had the lowest friability at 0.462% and Brand B the highest at 0.821%, guaranteeing that few tablets would break while being handled. All of the brands exhibited consistent, high purity levels; Brand D was above 100%, suggesting potential overage, while Brand B had the lowest, but still respectable, purity at 95.11%. The commencement of action may have been influenced by the different disintegration times; Brand C disintegrated the fastest at 4:15 minutes and Brand E took the longest at 7:41 minutes.

Effective therapeutic action was ensured by the dissolution research, which showed efficient drug release for all brands. Brands A and E exhibited quick initial dissolving, but at the end of the 60 minutes, all brands had nearly full drug release, demonstrating their bioequivalence and suitability for successfully managing diabetes.

In conclusion, all brands fulfilled the necessary requirements for quality and performance, even though there were little variations in hardness, friability, and disintegration times. These results imply that Brands A, B, C, D, and E are interchangeable, meaning that patients can move between them without worrying about their safety or effectiveness. This interchangeability ensures ongoing and efficient diabetes control, especially in clinical settings where availability and cost can affect medication decisions.

Dissolution Study:

The cumulative percentage of medication release over time was used to assess the dissolving profiles of several brands of metformin hydrochloride tablets. The table-2 displays the data of dissolution study.

Figure 2. Percentage drug release of drug

Significant variations in drug release rates and consistency are revealed by the in vitro dissolution profile investigation of Five distinct brands of tablets containing metformin hydrochloride: Brands A, B, C, D, and E. These changes in formulation may have an effect on patient efficacy and preference.

Starting with Brand A, this brand showed a steady and consistent release profile throughout the test period. At 60 minutes, Brand A achieved 92.18% ± 1.1 drug release, which is slightly lower than some of the other brands but indicates a reliable release rate. The standard deviation values remained relatively low, suggesting consistent dissolution behavior across different tablet samples. Brand A’s consistent release rate makes it a dependable option for patients who require stable and predictable drug release, though it might take slightly longer to reach peak effectiveness compared to faster-dissolving brands.

Brand B demonstrated the highest overall release rate, reaching 96.16% ± 0.8 at 60 minutes, with relatively low variability. This rapid and near-complete release suggests that Brand B could be an ideal choice for patients needing a quick onset of therapeutic action. The low standard deviation values further indicate consistent release across different tablets, enhancing its reliability. Brand B’s profile suggests it could provide efficient symptom relief and might be preferable for patients who need rapid glucose control.

Brand C had the lowest cumulative release percentage, reaching 90.15% ± 1.6 at 60 minutes. While this release rate is within acceptable limits, Brand C’s slower release profile may offer a more gradual onset of action. The higher standard deviation values observed at certain intervals, such as at 10 and 15 minutes, suggest variability that may impact dosing predictability. For patients requiring a slower but steady release, Brand C could be suitable; however, its variability suggests it might not be the first choice for those needing consistent and immediate control.

Brand D displayed a moderate release rate with a strong initial release at the 15-minute mark, reaching 70.28% ± 1.4. By 60 minutes, Brand D achieved 94.21% ± 0.9 release, showing a relatively quick onset followed by steady release. This brand’s dissolution profile suggests it may balance between rapid onset and prolonged release, providing both quick and sustained action. Brand D's consistent standard deviation values make it a reliable choice for patients who need a balance of immediate and extended therapeutic effects.

Brand E, with a release of 97.15% ± 1.5 at 60 minutes, displayed one of the highest overall dissolution rates, closely following Brand B. Its profile indicates fast and nearly complete dissolution, which would be beneficial for patients needing a rapid therapeutic response. However, slightly higher variability at later time points might make it less predictable in some cases, though still within acceptable limits. Brand E’s high dissolution rate and near-complete drug release suggest it is suitable for patients needing quick glucose control with a reliable outcome, similar to Brand B.

In summary, while all five brands meet basic dissolution criteria, Brand B and Brand E stand out for their high release rates, making them suitable for patients requiring rapid therapeutic action. Brand A offers a steady release, providing a predictable and stable option. Brand C might be more appropriate for patients who prefer a gradual onset, though its variability may impact consistency. Brand D provides a balance between rapid initial release and sustained action, positioning it as a versatile option. This analysis indicates that patients can switch between brands based on therapeutic needs without compromising on quality, as all brands demonstrate adequate release profiles. For patients prioritizing cost, interchangeability between these brands is viable, especially between those with similar release profiles like Brand B and Brand E.

Dissolution Kinetic Study:

To comprehend the drug release mechanism, a number of kinetic models were fitted to the dissolution data. The data is displayed in the table-3.

The five brands of metformin hydrochloride tablets—Brands A, B, C, D, and E—have dissolution kinetic characteristics that show how closely each brand adheres to different kinetic models, which aids in comprehending the release mechanisms.

Zero Order Model examines if the drug release is constant over time, ideal for controlled-release formulations. Here, Brand C (0.8584) and Brand E (0.8313) showed higher correlation coefficients, suggesting they may have a more constant release rate compared to other brands. This characteristic could make them suitable for patients who benefit from a steady, controlled release of the drug, providing prolonged therapeutic effects²³.

First Order Model believes that the rate of drug release is depending on concentration. All brands showed a strong fit to the first-order model, with Brand E (0.9878) and Brand C (0.9712) showing the highest correlation coefficients. This implies that for most brands, drug release is proportionate to the quantity of drug left, resulting in faster release rates initially that slow down as the drug concentration decreases^24,25. This is typical of immediate-release formulations, which may offer rapid therapeutic effects upon administration.

Higuchi Model evaluates release via a process that is regulated by diffusion. This type works well for all brands, but Brand C(0.9327) and Brand B(0.9266) had the highest values, indicating diffusion as a significant mechanism of drug release for these brands²⁶. Patients using these brands may experience a controlled diffusion-driven release, which can maintain drug levels within a therapeutic range for an extended period²⁷.

Korsmeyer-Peppas Model is used to evaluate whether the release mechanism is Fickian (diffusion-controlled), non-Fickian, or a mix of diffusion and erosion. Most brands exhibit values close to each other, with Brand B (0.9355) and Brand E (0.935) showing the highest fit. This suggests that these brands might follow a non-Fickian release, indicating a combination of both diffusion and erosion mechanisms, which may result in more complex release profiles beneficial for consistent therapeutic effect.

Hixson-Crowell Cube Root Law investigates whether tablet degradation has an impact on the release mechanism.. The highest correlation was observed in Brand E (0.9665) and Brand C (0.9464), suggesting that tablet erosion may play a notable role in the release of the active ingredient for these brands. This erosion-based release could support a more gradual reduction in tablet size, contributing to sustained drug delivery over time²⁸.

Overall, the dissolution kinetic analysis highlights that Brand C and Brand E show strong fits across multiple models, particularly Zero Order and Hixson-Crowell, indicating potential suitability for patients who need sustained or controlled release. Brand B demonstrates a strong alignment with the Korsmeyer-Peppas model, suggesting a mixed release mechanism that may be beneficial for patients seeking balanced release kinetics. For patients, this means they can select a brand based on their therapeutic needs—whether for immediate release, controlled diffusion, or sustained effect—while remaining confident in the interchangeability of these brands based on consistent release mechanisms²⁹.

CONCLUSION:

The interchangeability of the several brands of metformin hydrochloride tablets that are sold in Satara, such as Brands A, B, C, D, and E, is significantly reassured by this study. With a few minor variances that have no bearing on their effectiveness, all of these brands satisfy the necessary quality requirements for size, uniformity, hardness, and purity. For instance, while Brand E exhibited the highest hardness and purity, and Brand B showed the fastest and most efficient drug release, all brands ultimately delivered consistent therapeutic outcomes. This means that patients can confidently switch between these brands without worrying about differences in effectiveness or quality. This flexibility allows for better adherence to medication regimens, as patients can choose the most cost-effective option available at their pharmacy. The consistent drug release profiles and high-quality standards ensure that switching brands will not affect the management of their diabetes. Thus, patients have the assurance that they can maintain effective treatment while also benefiting from potential cost savings, making diabetes management both effective and economically feasible.

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Received on 06.02.2025 Revised on 18.03.2025

Accepted on 16.04.2025 Published on 12.07.2025

Available online from July 21, 2025

Asian Journal of Pharmaceutical Analysis. 2025; 15(3):163-169.

DOI: 10.52711/2231-5675.2025.00025

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Brand Name	Thickness(cm)	Uniformity of Weight(g) ± SD	Hardness (kg/cm²⁾	% Friability	% purity	Disintegration Time (min)
Brand A	0.46	0.547±0.22	7.45±0.21	0.462	97.71	4:52
Brand B	0.47	0.524±0.11	6.74±0.11	0.821	95.11	7:21
Brand C	0.38	0.684±0.15	7.98±0.18	0.168	96.56	4:15
Brand D	0.35	0.593±0.09	5.60±0.13	0.110	102.37	5:21
Brand E	0.48	0.597±0.10	5.60±0.13	0.213	96.37	7:41

Time	5	10	15	30	45	60
Brand A	34.15±1.2	44.18±0.6	66.4±0.9	83.16±1.1	85.06±0.7	92.18±1.1
Brand B	32.18±0.8	43.15±1.7	65.19±1.5	82.14±0.6	88.19±1.4	96.16±0.8
Brand C	28.12±0.9	41.35±1.6	61.18±1.9	75.14±1.5	81.15±0.8	90.15±1.6
Brand D	30.09±1.5	45.29±1.9	70.28±1.4	85.15±1.4	90.17±1.7	94.21±0.9
Brand E	30.12±0.7	48.06±1.1	68.14±1.8	84.09±0.7	91.16±0.6	97.15±1.5

Brand Name	Zero Order Model	First Order Model	Higuchi Model	Korsmeyer-Peppas Model	Hixson-Crowell Cube Root Law
Brand A	0.818	0.9477	0.9054	0.9349	0.919
Brand B	0.8534	0.9778	0.9266	0.9355	0.9623
Brand C	0.8584	0.9712	0.9327	0.9433	0.9464
Brand D	0.7565	0.9439	0.8562	0.8929	0.8875
Brand E	0.8313	0.9878	0.9211	0.935	0.9665