IPD 2026 / Acetylcysteine
INTEGRATED PRODUCT DEVELOPMENT — PACY2000A / PACY2001A

Acetylcysteine 20 %
w/v Nebuliser
Solution

A sterile aqueous mucolytic solution delivered by nebuliser, developed to loosen and clear viscous mucus secretions in respiratory disease. Formulated, manufactured and assayed as a single integrated exercise.

DOSAGE FORM
Solution — aqueous, sterile, single-use
AILMENT
Viscous mucus secretions in respiratory conditions
ROUTE
Inhalation via nebuliser
ASSAY
Reverse-phase HPLC with UV detection

The challenge

Stability starts with chemistry.

Acetylcysteine's free thiol group is prone to oxidation, requiring careful control of antioxidant selection, pH, and exposure to air and light during formulation. This instability also defines the analytical requirements of the project.

The HPLC-UV method must be capable of detecting degradation, not only quantifying the intact drug. This is where formulation and pharmaceutical chemistry begin to shape one another.

ACETYLCYSTEINE — THE FREE THIOL GROUP AT LEFT IS THE SITE OF OXIDATION. IN THE VIDEO, THE YELLOW HIGHLIGHT MARKS THE THIOL GROUP.
TWO SIDES OF ONE PRODUCT

Formulation and analysis were
developed together.

The formulation and the analytical method were developed together, each one shapes what the other has to do.

PART A

Pharmaceutics

Formulation of a stable 20 % w/v acetylcysteine solution, with emphasis on antioxidant selection, pH control, and packaging to limit oxidative degradation.

View formulation →
INTEGRATED
PRODUCT
DEVELOPMENT
PART B

Pharmaceutical chemistry

Validation of an HPLC-UV method for acetylcysteine quantification, referenced against the BP 2022 monograph and cross-checked by iodometric titration.

View method validation →
STRENGTH
20 % w/v
REFERENCE MONOGRAPH
BP 2022, Acetylcysteine Injection
PRIMARY METHOD
HPLC-UV
CROSS-CHECK
Iodometric titration

From formulation to patient benefit

One seamless development process.

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Raw materials

API & excipients

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Formulation

20 % w/v

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Manufacturing

Sterile solution

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Analysis

HPLC-UV

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Validation

Cross-check

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Final product

Inhalation therapy

Group members

Husna Nana 2980564
Madeeah Seedat 2946610
Wilmari Olivier 2010150
Sumayyah Chughtai 2965657
Lidija Lazovic 2943334
Raeesa Rashid 2800819
Aisha Patel 2996407