The document provides a detailed overview of the drug canagliflozin, including its uses for treating type 2 diabetes, its approval status, and manufacturing processes. It outlines the synthesis of the drug substance, the analysis required for both drug substance and drug product, and the various excipients used in formulation. Additionally, it includes a case study on drug product development and analysis techniques.

1. Pharmaceutical Industry
Drug Substance & Drug Product
Dr. Useni Reddy Mallu
Mobile: 7901020060
E-mail: info@manasalifesciences.com
Website: www.manasalifesciences.com

2. DS & DP Manufacturing

3. Drug Substance: Canagliflozin
 Canagliflozin, sold under the brand name Invokana, Sulisent, Prominad
 Used to treat type 2 diabetes.
 Canagliflozin was approved for medical use in the United States in 2013.
 Canagliflozin is an anti-diabeticmedication used to improve blood sugar control in
people with type 2 diabetes.
 It was developed by Mitsubishi Tanabe Pharma and is marketed under license
by Janssen.
 It is used together with exercise and diet.
 It is not recommended in type 1 diabetes. It is taken by mouth.
 Molar mass 444.52 g/mol
 Chemical formula: C24H25FO5S

4. Drug Substance Synthesis
Starting material-
1
Stage-3
Stage-2
Stage-1
Stage-4 Stage-5
Stage-6
Intermediate-2
Starting material-2
Starting material-3
Stage-7 (Final product)
Canagliflozin
Bi-product
Degradation
products
Intermediate-1

5. Impurity Profile
Intermediates
Bi Product
Degradation
Products

6. Drug Substance Analysis
1. Description
2. Identification (Chemical, NMR, MASS, FT-IR, UV, HPLC, TLC)
3. Clarity of solution
4. Melting Point
5. pH value
6. XRD test (polymorphism)
7. Water content
8. Loss on Drying
9. Residual solvents
10. Purity test
11. Assay
12. Microbial test
13. Particle size
14. TGA
15. DSC
16. Isomer content

7. Drug Product Case Study
Dry mixing
In-active (Excipients) 1, 2, 3)
Drying
Excipients-4 & 5
addition
Wet Granulation
Blending
Compression (un-coated tablets
Coating (coated tablets)
Packing
Excipient-6 addition
Canagliflozin
Active (API)
Ex. Lactose, HPMC, Mg stearate,
Povidone, Cellulose, Starch
Ex. Preservatives (parabens, benzoyl
alcohol)
Coating excipients (film coating,
colourants)
Possible degradation
products

8. Drug Product Analysis
1. Description
2. Identification (Chemical, NMR, MASS, FT-IR, UV, HPLC, TLC)
3. Physical parameters (thickness, Hardness)
4. Friability
5. Average weight
6. XRD test (polymorphism)
7. Loss on Drying
8. Residual solvents
9. Purity test
10. Assay
11. Microbial test
12. Isomer content
13. TGA
14. DSC
15. Preservatives content

9. Hold Time Study (Tablets)

10. Hold time Study (Capsules)

11. Questions
&
Answers