Evaluation and Comparative Study of Formulated, Branded & Generic Linagliptin Tablets; An Analysis of Quality Performance and Cost Effectiveness

Suvarna Kasi, R. Malliswari, Dr. B. Nagamani, K. Bhavana, G. Sai Lakshmi, R. Lalitha, B. Nikhil Sai, K. Bharathi, A. Ramya,

doi:10.5281/zenodo.17762266

Research Paper | Open Access
Volume 03 | Issue 11 | Article Id IJPS/250311662

Evaluation and Comparative Study of Formulated, Branded & Generic Linagliptin Tablets; An Analysis of Quality Performance and Cost Effectiveness
Suvarna Kasi* R. Malliswari Dr. B. Nagamani K. Bhavana G. Sai Lakshmi R. Lalitha B. Nikhil Sai K. Bharathi A. Ramya
Viswanadha Institute of Pharmaceutical Sciences, Visakhapatnam, Andhra Pradesh.

Abstract

The Aim of the present work is to formulate, evaluate and compare the quality performance, drug release profile, and cost-effectiveness of formulated, branded, and generic Linagliptin SR tablets. Post- compression tests were conducted to assess quality as well as physicochemical equivalence of Formulated, Branded and Generic Linagliptin tablets. The study confirmed that the formulated, generic and branded Linagliptin tablets complied with the official specification for weight variation, hardness, friability, disintegration and dissolution. No significant difference was observed in the content of active drug and parameters of the branded and generic products. This establishes the Quality of generics is same as for their branded version. The differences observed in value regarding the cost of these two versions of drug though the manufacturing cost of the generic is less as compared to branded but it has lucrative profit margin to its sales. Dissolution studies revealed that drug release percentages for the generic, branded, and formulated Linagliptin SR tablets were 74%, 78%, and 70%. Further analysis showed that Linagliptin follows zero-order kinetics, indicating a consistent and controlled drug release over time. Additionally, the Korsmeyer-Peppas model confirmed that the drug release mechanism follows Fickian diffusion, suggesting a diffusion-controlled release pattern. FTIR studies demonstrated no significant interactions between the drug and excipients in the formulations. This confirms the stability of Linagliptin in the presence of selected excipients, reducing the risk of any potential incompatibility that could affect drug efficacy or safety. On the basis of cost effectiveness, we found that generic formulation is cost effective when compared to branded and formulated. The result indicated that the formulated, generic and branded tablets fulfilled the required official specification and thus assures that generic drugs are also bioequivalent to ethical drugs if all the quality control parameters are being maintained.

Keywords

Cost Effectiveness, Generic Linagliptin, Quality Performance

Introduction

Today India is known as world’s pharmacy due to the giant production facilities in the country. It approximately caters 20% of global generic drug supply. Indian pharmaceutical sector may grow to US $100 billion in near future. Pharmaceuticals export from India stood at US $16.3 billion in FY20. As of November 2020, India exported pharmaceuticals worth US $15.86 billion in FY21. Pharmaceutical exports from India stood at US $16.28 billion in FY20. There are two general terms used to describe medicinal products.

Innovator/Branded product [1]- A product which is developed for the first time by researcher and approved by regulatory agency. When a drug is under patent protection, the company markets it under its brand name. When the drug is off patent (no longer protected by patent), the company may market its product under either the generic name or brand name. Other companies that file for approval to market the off-patent drug must use the same generic name but can create their own brand name. As a result, the same generic drug may be sold under either the generic name (for example, ibuprofen) or one of many brand names (such as Advil or Motrin).
Generic product [2] It is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

MATERIALS AND METHOD

Different brands of Generic and branded Linagliptin Tablets.

Different Samples of Linagliptin Tablets

Table No.1: Materials and Manufacturers:

S. No.	Ingredients And Reagents	Manufacturer / Suppliers
1.	linagliptin	Gifted by pharmaceutical company
2.	Eudragit E-100	Gifted by pharmaceutical company
3.	Starch	Thermo Fisher Scientific IndiaPvt.Ltd.
4.	Talc	Labogens Pvt.ltd.
5.	Magnesium stearate	Numex Chemical Products(India)

Table No.2: Formulation of Linagliptin Tablets

S. No	Ingredients	Quality	Category
1	Linagliptin	50mg	Anti-diabetic drug
2	Eudragit E-100	1000mg
3	Starch	1500mg	Binder
4	Talc	20 mg	Glidant
5	Magnesium stearate	30mg	Lubricant

RESULTS & DISCUSSION

Table No.3: Calibration curve for Linagliptin

S.no

Concentration

Absorbance

0.14

0.28

0.398

0.565

0.705

DRUG SOLUBILITY

Table No.4: Different solvents (aqueous and organic) were used to test the API sample's solubility.

S. No.	Solvent	Solubility
1	Water	Very slightly soluble
2	ethanol	Sparingly soluble
3	methanol	Soluble
4	P^H7.4 buffer	Soluble

Table No.5: Formulation Of Linagliptin Tablet

S. No	Polymers	Quantity
1	Linagliptin	50mg
2	Eudragit E-100	1000mg
3	Starch	1500mg
4	Talc	20 mg
5	Magnesium stearate	30mg

FTIR STUDIES

Linagliptin: 3300-3500 cm^-1OH stretch was observed.2800 CH cm^-1 bend peak was observed.
Starch: Median peak and3674cm^-1 indicating the presence the hydroxyl group.
Linagliptin, Eudragit E100, Starch: OH stretching was observed at 3748 cm^-1 from starch, General amine range was at 3857 cm^-1, CH bend bond was observed at 2833 cm^-1, C=C aromatic compound was observed at 1541 cm^-1, ketone group at 1656 cm^-1,C=O stretching was observed at 1600-1700 cm^-1, CH3 stretch was observed at 1317-1350cm^-1, alkyl peak was observed at 2000cm^-1.
Eudragit E100: C-C stretch was observed at 1000-1200cm^-1

FTIR Spectrum of Linagliptin

FTIR Spectrum of Eudragit E-100

FTIR Spectrum of Starch

FTIR Spectrum of Formulation (Linagliptin, Eudragit E-100 And Starch)

FTIR spectra’s was indicated no interaction between linagliptin & excipients used in the formulation.

Post Compressional Studies of Linagliptin Tablets

Table No.6: Post compression parameters of Linagliptin tablets

Sno	Drugs	Weight variation	Friability (%)	Hardness (Kg/cm²)	Disintegration (Min)
	Branded tablets
1.	B1	4.477±5.472	0.298	10	21
	Generics tablets

G1 G2 G3 G4 G5

4.477±5.472

3.773±5.660

7.14±4.76

8.433±9.638

7.78 ±10.17

15.6± 8.43

0.120

0.166

0.133

0.191

0.149

0.154

Formulated tablet

13.38±5.2

0.046

RESULT: The results which is shown in table complied with official standard values, all the values are within acceptable limits.

B1-Dynaglipt-L

G1- linaprex-5

G2-linares-E

G3-linapride

G4-Trajenta-5

G5- Ondero-5

G6- linaworth-5

Table no.7: Dissolution data of Generic Linagliptin tablets

S. No	Time (Mins)	%Amount of Drug release
S. No	Time (Mins)	G1	G2	G3	G4	G5	G6
1.	30	6.5	6.4	6.6	6.8	6.9	6.5
2.	60	15.4	15.0	15.2	15.6	15.4	15.3
3.	120	22	21	22.5	21.3	21.6	22
4.	180	34	33	32.4	33.6	333.8	32.8
5.	240	42	41	40	42.5	42	41.5
6	300	51	50	50.8	50	51	52
7.	360	61.5	61	60	60.3	60.1	60.3
8	420	71	70	71	72	71.5	72
9.	480	74	73	72	73	72	71

Table No.8: Dissolution data of Branded Linagliptin tablets

S.no	Time (mins)	%Amount of drug release
1	30	7.2
2	60	18
3	120	25
4	180	38
5	240	45
6	300	54
7	360	62
8	420	70
9	480	78

Table no.9: Dissolution data of Formulated Linagliptin Table

S.no	Time (mins)	%Amount of drug release
1	30	5.8
2	60	10.1
3	120	21
4	180	32
5	240	45
6	300	52
7	360	60
8	420	64
9	480	70

Table No.10: Amount Of Drug Release from Generic Branded Formulated

S.no	Tablet	Amount of drug release
1.	Formulated	70%
2.	Generic	74%
3.	Branded	78%

Zero order plots of Linagliptin tablets (Formulated, Branded, Generic Tablets)

First order plots of Linagliptin tablets (Formulated, Branded, Generic Tablets)

Higuchi model of Linagliptin tablets (Formulated, Branded, Generic Tablets)

Korsmeyer-Peppas model of Linagliptin tablets (Formulated, Branded, Generic Tablets)

Table No.11: Correlation coefficient values

S. No	Tablets	Correlation coefficient values
S. No	Tablets	Zero order release	First order release	Higuchi
1.	Formulated	0.9843	0.996	0.9873
2.	Generic	0.9952	0.9815	0.9952
3.	Branded	0.9974	0.9804	0.9974

Table No.12: N values of Korsmeyerpeppas Graph

N values of korsmeyerpeppas graph
Formulated	Generic	branded
0.3905	0.3893	0.3683

DISCUSSION

The present study aimed to evaluate and compare the quality performance, drug release profile, and cost-effectiveness of formulated, branded, and generic Linagliptin SR tablets.post- compression tests were conducted to assess the physical and mechanical properties of the tablets, all of which complied with official pharmacopoeia specifications, indicating satisfactory formulation quality.Dissolution studies revealed that drug release percentages for the generic, branded, and formulated Linagliptin SR tablets were 74%, 78%, and 70%.Further analysis showed that Linagliptin follows zero-order kinetics, indicating a consistent and controlled drug release over time.Additionally, the Korsmeyer-Peppas model confirmed that the drug release mechanism follows Fickian diffusion, suggesting a diffusion-controlled release pattern.FTIR studies demonstrated no significant interactions between the drug and excipients in the formulations. This confirms the stability of Linagliptin in the presence of selected excipients, reducing the risk of any potential incompatibility that could affect drug efficacy or safety.On the basis of cost effectiveness, we found that generic formulation are cost effective when compared to branded and formulated.The result indicated that the formulated, generic and branded tablets fulfilled The required official specification and thus assures that generic drugs are also bioequivalent to ethical drugs if all the quality control parameters are being maintained.

SUMMARY AND CONCLUSION

This study evaluated the quality, physicochemical properties, and drug release behaviour of formulated, branded, and generic Linagliptin tablets. All formulations were found to comply with official standards for weight variation, hardness, friability, disintegration, and dissolution, indicating consistent manufacturing quality. Drug content analysis showed no significant differences between the branded and generic products, confirming that generic Linagliptin tablets maintain quality comparable to their branded counterparts. FTIR compatibility studies revealed no interaction between Linagliptin and the excipients used, ensuring stability of the formulations. Drug release kinetics demonstrated zero-order release, while the Korsmeyer–Peppas model indicated Fickian diffusion as the primary release mechanism. The percentage drug release was observed as: branded – 78%, generic – 74%, formulated – 70%, showing acceptable performance for all versions. Cost analysis highlighted that generic formulations are more cost-effective due to lower production costs and higher profit margins, whereas the formulated SR tablet can be further optimized to reduce cost and improve release characteristics. Overall, the findings confirm that generic drugs can be bioequivalent to branded drugs when proper quality control standards are maintained, and that formulation optimization can enhance performance of in-house SR products.Future work should focus on refining the formulated Linagliptin SR tablet to improve its drug release profile and further close the gap with branded alternatives.

ACKNOWLEDGEMENT

I take this privilege and pleasure to acknowledge the contribution of many individuals who have been inspirational and supportive throughout my work undertaken and endowed me with most precious knowledge to see success in my attempt. My work bears the imprint of all those people First of all I express my sincere thanks and heartfelt indebtedness to respected Dr. Nagamani Bolla, Professor, Department of Pharmaceutics, Viswanadha Institute of Pharmaceutical Sciences, Visakhapatnam. There have been able to look at things in a better way providing me with an in-depth understanding encouragement and moral support leads to complete my dissertation work successfully. I sincerely thankful to our principal Dr. P. Uma Devi, for providing me the most valued suggestions to carry out this dissertation work successfully.

REFERENCES

Overview of Generic Drugs and Drug Naming - Drugs - Merck Manual Consumer Version (merckmanuals.com)
Generic drug - Wikipedia
JETIR Research Journal
IJNRD2407137.pdf
Linagliptin: Uses, Interactions, Mechanism of Action | DrugBank Online
pharmawiki.in)
A comparative evaluation of the quality & price of generic medicine with their branded counterparts, Pharmatutor, 2016, 4(10),pg:43-49.
Singal, G.L.; NandaArun; Kotwani, Anita, A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India,Indian Journal of Pharmacology,Mar–Apr 2011,43(2),Pg: 131-136,
Mansi Kishor Mulik, Vaibhav Shashikant Patil, Mr. Rohan R. Vakhariya, Comparative Study of Evaluation of Generic and Branded Metformin HCl (500mg) Tablets, International Journal of Novel Research and Development,2024,9(7), b338-b351.
Ankit Gour, Saransh Puri, Maneesh Sahu, Dr. Satish Naya, Comparative Exploration of Generic versus Branded Medicinal Products, Journal of Emerging Technologies and InnovativeResearch,2024,11(7), Pg:e109-113.