Introduction to research work on

(PHRGA019)

Comparative study of current registration requirements of SITAGLIPTINE PHOSPHATE

TABLETS 50mg in targeted Latin American countries.

PRESENTED BY: PROJECT SUPERVISOR:

Solanki Ronak P. Dr. Adil Patel
22MPHRGA010 Assistant professor
M.PHARM (REGULATORY AFFAIRS) Department of pharmaceutics &
Pharmaceutical technology

Ramanbhai Patel Collage Of Pharmacy

Charotar University of Science & Technology 1
 01 Introduction

Ta b l e o f
contents
02 Literature Review

03 Aim and Objectives

04 Rationale

05 Plan of work

06 References

2
 Introduction

SITAGLIPTINE PHOSPHATE
Sitagliptin Phosphate
 It is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough
insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels

 According to the International Diabetes Federation.

Specific Region Total case of population Total cases of diabetes in adults

Chile 13,762,500 1,747,100

Mexico 83,741,600 14,123,200
Dominican Republic 6,832,400 865,300
Nicaragua 4,066,000 365,800
Honduras 5,887,600 268,200
Bolivia 6,951,200 395,900
https://idf.org/our-network/regions-and-members/south-and-central-america/members
3
 Introduction

 Diabetes is a chronic disease that affects millions of people worldwide. One of the medications used to
treat diabetes is Sitagliptin phosphate tablet 50mg. However, the registration requirements for this
medication can vary from country to country.

 The study will examine the regulatory frameworks, clinical trial requirements, and other factors that affect
the registration process in each country. By comparing the registration requirements in these countries, this
study aims to identify similarities and differences that can inform future efforts to streamline the
registration process and improve access to this important medication

4
 Introduction
Dominican
Country Regulatory Authority Mexico Republic

Nicaragua
Bolivia Agencia Estatal de
Medicamentos y Tecnologías
en Salud (AGEMED) Honduras

Chile Instituto de Salud Pública (ISP)

Dominican republic Dirección General de

Medicamentos, Alimentos y
Productos Sanitarios
(DIGEMAPS) Bolivia

Honduras Directorate of general health

regulation
Chile

Mexico (COFEPRIS) Decentralized by

ministry of health

Nicaragua Ministry of Health (MINSA

 Literature Review
Sr. Article Title Author Journal Name & Published
no. Year
1 Effect of insulin degludec versus A. Philis-Tsimikas, , S. Del Prato, I. Diabetes, Obesity and
sitagliptin in patients with Satman, A. Bhargava. Metabolism © (2013)
type 2 diabetes uncontrolled on oral
antidiabetic agents
2 Pancreatic Safety of Sitagliptin in John B. Buse, M. Angelyn Bethel, The Journal Of Clinical Applied
the TECOS Study Jennifer B. Green, Susanna R. And registration Diabetes care
Stevens. Volume 44 (2017)

3 Efficacy and safety of the addition of Muhammad Yazid Jalaludin, Asma Pediatric Diabetesn volume 23
sitagliptin to treatment of youth with Deeb, Philip Zeitler, Raymundo Issue 8 (2022)
type 2 diabetes and inadequate Garcia,
glycemic control on metformin
without or with insulin
4 Generic and similar products in Latin Storpirtis, Sílvia | Gai, Maria Nella Pharmaceuticals, Policy and Law
American countries: Current aspects | Cristofoletti, Rodrigo (2014)
and perspectives on bioequivalence
and biowaivers

6
 Aim and Objectives

Aim
Comparative study of current registration requirement of SITAGLIPTINE PHOSPHATE TABLETS 50mg in
Chile, Mexico, Dominican Republic, Nicaragua, Honduras, Bolivia.

Objectives
 To identify similarities and differences in the registration requirements for Sitagliptin Phosphate 50mg Tablet
among the selected countries.
 To provide recommendations for improving the registration process for Sitagliptin Phosphate 50mg Tablet in
the selected countries.
 To analyze whether local clinical trials, bioequivalence studies, or reliance on international data are required
for Sitagliptin Phosphate 50mg registration in each country.

7
 Rationale

A comparative study of the current registration requirements for Sitagliptin Phosphate 50mg Tablet in Chile,
Mexico, Dominican Republic, Bolivia, Nicaragua, and Honduras could help identify similarities, differences and
challenges in the registration process.

The registration requirements for Sitagliptin Phosphate Tablet 50 mg may differ among the selected countries,
which could impact access to the medication.

Evaluating potential barriers for harmonization of registration process for Sitagliptin Phosphate tablet 50mg in the
selected countries could help identify areas for improvement in the harmonization of registration process.

Contributing to the knowledge base on the registration requirements for Sitagliptin Phosphate 50mg Tablet in
Latin America and the Caribbean Islands could help inform future research and policy decisions related to
diabetes treatment in the specified region.

8
 Plan of work
Objectives Months
AUG SEP OCT NOV DEC JAN
Literature review
To study the regulation of Sitagliptin
Phosphate 50mg tablet in Chile, Mexico,
Dominican Republic, Nicaragua,
Honduras, Bolivia

To Compare the regulations

Dossier preparation
Thesis writing

Completed Work Remaining Work

9
 References

1. Plosker, G. L. (2014). Sitagliptin: A review of its use in patients with type 2 diabetes
mellitus. Drugs, 74(2), 223–242. https://doi.org/10.1007/s40265-013-0169-1
2. Gallwitz, B. (2007). Review of sitagliptin phosphate: a novel treatment for type 2 diabetes. Vascular
Health and Risk Management, 3(2), 203–210. https://doi.org/10.2147/vhrm.2007.3.2.203
3. Formulation And In vitro evaluation of bilayer tablets of sitagliptin phosphate. (n.d.). Ijpsjournal.com.
Retrieved September 26, 2023, from https://ijpsjournal.com/SingleArticle/Formulation-And-In-vitro-
Evaluation-Of-Bilayer-Tablets-Of-Sitagliptin-Phosphate
4. Ramírez-Telles, M., & Argotti-Rodríguez, U. (2022). Regulation of drug prescribing information in Latin
America and the Caribbean. Therapeutic Innovation & Regulatory Science, 56(4), 536–551.
https://doi.org/10.1007/s43441-022-00396-y
5. Chile. (2023, April 25). International Diabetes Federation. https://idf.org/our-network/regions-and-
members/south-and-central-america/members/chile/
6. Mexico. (2023, April 25). International Diabetes Federation. https://idf.org/our-network/regions-and-
members/north-america-and-caribbean/members/Mexico/

10
 References

6. Dominican Republic. (2023, April 25). International Diabetes Federation.

https://idf.org/our-network/regions-and-members/south-and-central-america/members/dominican-republic/
7. Nicaragua. (2023, April 25). International Diabetes Federation. https://idf.org/our-network/regions-and-
members/south-and-central-america/members/nicaragua/
8. Nicaragua. (2023, April 25). International Diabetes Federation. https://idf.org/our-network/regions-and-
members/south-and-central-america/members/nicaragua/
9. Bolivia. (2023, April 25). International Diabetes Federation. https://idf.org/our-network/regions-and-
members/south-and-central-america/members/bolivia/

11
 n k s f o r
Tha
s t e n i n g
li
12