Course Overview
The Dissolution Testing Training Course is a
comprehensive industrial skill-building program tailored for pharmaceutical
students and professionals working in Quality Control, Quality Assurance, and
R&D laboratories. Dissolution testing is a critical quality parameter for
oral solid dosage forms such as tablets, capsules, and soft gels because it
evaluates how efficiently and consistently a drug releases its active
pharmaceutical ingredient (API) into the body. This course begins with a strong
foundation in dissolution science, including concepts such as dissolution rate,
solubility, diffusion, sink conditions, and factors influencing drug release
like pH, agitation, and formulation excipients. Learners will gain a complete
understanding of how dissolution testing supports product quality,
bioavailability prediction, stability studies, and regulatory submissions. The training provides detailed coverage of
USP, BP, and IP apparatus types, focusing primarily on Apparatus 1 (Basket) and
Apparatus 2 (Paddle), along with advanced tools like Apparatus 3 (Reciprocating
Cylinder), Apparatus 4 (Flow-Through Cell), and Apparatus 5, 6, 7 for
specialized dosage forms. Participants will learn how to select appropriate
media, volumes, temperature settings, and sampling time points for different
formulations. The course explains filtration, sample handling techniques, and
how to minimize errors caused by foaming, degassing issues, cone formation
under paddles, and hydrodynamic distortion. Learners will gain practical
exposure to method execution, including media preparation, pH adjustment,
system suitability testing, sampling procedures (manual and auto-samplers), and
sample analysis using UV–Vis or HPLC instruments. There is a strong emphasis on regulatory
requirements including ICH, USP General Chapters, USFDA guidelines, and
dissolution performance acceptance criteria. Trainees will understand the
importance of Dissolution Profile Comparison using f2 similarity factor,
biowaiver concepts, IVIVC (in-vitro in-vivo correlation), and how dissolution
data supports formulation development during ANDA and NDA filings. With
real-time industrial scenarios, the course develops capability in investigation
handling for Out-of-Specification (OOS), Out-of-Trend (OOT) results, and impact
assessments on product quality. Documentation excellence is practiced using
Good Documentation Practices (GDP) and audit-ready reporting to maintain
complete compliance with GMP and GLP requirements. Data integrity is emphasized
throughout the course ensuring every result is attributable, legible,
contemporaneous, original, and accurate under ALCOA+ principles. This training also includes method validation
concepts such as specificity, linearity, accuracy, precision, robustness, and
filter compatibility studies. Troubleshooting is a major component;
participants learn how to overcome common issues like paddle wobbling, basket
deformation, equipment vibration, improper media degassing, and sampling loss.
Instrument qualification and calibration procedures such as Performance
Verification Testing (PVT), rpm calibration, and temperature mapping are
included. Participants will also gain insight into dissolution automation,
online sampling integration with UV/HPLC, and 21 CFR Part 11 compliant data
systems used in modern labs. By the end of the course, learners will be
ready to independently run dissolution tests for routine QC batches, stable and
accelerated stability studies, method development for R&D, and comparative
dissolution studies for regulatory submissions. This training not only enhances
theoretical and practical knowledge but also boosts job confidence and
employability in major pharmaceutical companies.
Who Should Enroll
Ideal for B.Pharm, M.Pharm, B.Sc, M.Sc
chemistry or life science students preparing for analytical/pharma careers.
Fresh graduates seeking roles in QC, QA, and R&D laboratories. Working
professionals wanting to upgrade their technical skills and regulatory
knowledge in dissolution testing. Individuals transitioning to formulation
development, regulatory affairs, or analytical method development roles.
What You'll Learn
Principles of drug dissolution and
bioavailability relevance. Selection and operation of dissolution apparatus
including paddle, basket, and advanced systems. Media selection strategies
including pH adjustment, surfactants, and degassing techniques. Complete
hands-on experimentation: media preparation, sampling, filtration, and
calculation of % drug release. System suitability criteria, method transfer,
and method validation elements supporting regulatory compliance. Dissolution
profile comparison and f2 calculation for generic product approvals. Good
Documentation Practices, GLP guidelines, and regulatory documentation
expectations. Instrument calibration, troubleshooting, preventive maintenance,
and PVT execution. Best practices for avoiding common operational errors and
ensuring consistent test reproducibility. Integration of dissolution data with
UV–Vis and HPLC analysis pipelines.
Prerequisites
Basic understanding of analytical chemistry and pharmaceutical dosage forms. Familiarity with lab safety practices and solution preparation is preferred. No prior dissolution testing experience required; beginners are welcome
Curriculum
Detailed curriculum information will be available soon.
Course Format
This course offers a comprehensive learning experience with interactive content.
Course Materials
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