L 5 - NDDS/TT

Key Responsibilities & Accountability – Handled Individually

1. Development of Inhalation Dosage Forms: Independently plan and execute formulation development

of Nasal Spray, Solutions, Suspensions, Drops etc. including single and combination products.

2. Selection of the compatible excipients based on their properties as required in such formulations.

3. Selection of suitable devices for such formulations.

4. Pre-formulation Studies: Evaluate API and excipient characteristics such as particle size distribution,

morphology, density, moisture content, flow properties, crystallinity, hygroscopicity etc.

5. Particle Engineering Strategy: Detailed understanding of morphology, particle size distribution,

polymorphism and other essential physical properties of the drug substances.

6. Deep understanding of the process variables for lab-scale and scale-up: Develop and optimize

processes considering mixing time, speed, fill weight, segregation risk, content uniformity &

viscosity of the formulation.

7. Device–Formulation Compatibility: Evaluate compatibility of the formulation with different

devices/pumps and optimize formulation considering device resistance and aerosolization

characteristics.

8. Product Performance Evaluation: Interpret critical performance data including:

a. Delivered Dose Uniformity / Uniformity of Delivered Dose

b. Droplet Size Distribution (DSD)

c. Plume Geometry

d. Spray Pattern

e. Device retention/deposition

9. Reference Product Characterization: Conduct systematic characterization of reference/marketed

products to understand formulation, device, physical characteristics, and critical performance

attributes for generic product development.

10. QbD-Based Development: Define and evaluate QTPP, CQAs, CMAs, and CPPs and apply risk

assessment, Design of Experiments (DoE), and scientific principles during formulation/process

optimization.

11. Stability Studies: Plan and evaluate stability studies and investigate the impact of temperature,

humidity, moisture uptake, packaging, and physical on product performance.

12. Technology Transfer: Execute formulation and process transfer from R&D to pilot/commercial

manufacturing sites and provide technical support during scale-up, exhibit/registration, validation,

and commercial batches.

13. Troubleshooting: Candidate should have experience related to troubleshooting.

14. Documentation: Prepare and review development reports, BOM/MFR, product development reports,

technology-transfer documents, protocols, risk assessments, QbD documents, and regulatory-support

documentation.

15. Literature & Patent Evaluation: Conduct scientific literature, innovator-product, regulatory, and

patent searches to support formulation strategy and identify potential development or patentability

opportunities.