Project plan for NDA
Clinton Rogers
A. Select an approved drug and dosage form, develop a TPP.
Drug: Aripiprazole, 2 mg capsules
Criteria Product Characteristics Target Attribute
Therapeutic Indication Major depressive disorder
Patient Population Adult, 18-65
Markets Global Meet global regulatory requirements
Route of Administration Immediate release oral
Treatment Duration Chronic Increase dose as needed
Dosage Form 2 mg capsule Opaque, low dose
Co-Administration Fasted, potentially with other antidepressants Differentiate from other medicines, mask taste
Pharmacokinetics Class BCS Class IV Ensure proper solubility
Package Configurations Opaque HDPE bottle Childproof, protect from light
Storage Ambient conditions
Handling Keep capsules
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Stability Protocol
Three batches of aripiprazole capsules will be made samples from these batches will be stored at 25°C ± 2°C/60% RH ± 5% RH over a period of 36 months. Samples will be tested in a matrix design, shown in the table below. This will determine the long term stability of the aripiprazole capsules.
Time (Months) Batch 1 Batch 2 Batch 3
0 Test Test Test
3 Test Test
6 Test Test
9 Test Test
12 Test Test Test
18 Test Test
24 Test Test
30 Test Test
36 Test Test Test
Intermediate stability tests will be performed on samples from these batches of capsules at 30°C ± 2°C/65% RH ± 5% RH over a period of 6 months. Accelerated stability tests will be performed on samples from these batches of capsules at 40°C ± 2°C/75% RH ± 5% RH over a period of 6 months. These will also be tested according to the following matrix design.
Time (Months) Batch 1 Batch 2 Batch 3
0 Test Test Test
1 Test Test
3 Test Test
6 Test Test Test
I. References
1. National Center for Biotechnology Information. PubChem Compound Database; CID=60795. https://pubchem.ncbi.nlm.nih.gov/compound/Aripiprazole Accessed April 30,
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