Dissolution testing is never a routine test. It is a highly customized, essential tool in pharmaceutical development — and the way it is designed determines whether the result predicts anything.
The experience and knowledge in pharmaceutical dissolution within PCL Research & Manufacturing focus on supporting preformulation studies and solid form selection.
We evaluate the physico-chemical properties of drug candidates to select the most appropriate solid form for further development, and perform biorelevant in-vitro tests to mimic fed and fasted state conditions and compare prototype formulations at the preclinical selection stage.
The design of the experiment is where the value is. A dissolution method that does not discriminate between forms will show that every candidate is equivalent, and a method that discriminates on an irrelevant variable will send development in the wrong direction. Getting this right early is what makes the later comparisons trustworthy.
The measurement is chosen for the decision it supports, from early form ranking to formulation comparison.
Equilibrium solubility across solvents, pH and temperature, measured on confirmed solid forms with the residual solid checked afterwards for conversion.
Intrinsic dissolution rate on compacted discs, which isolates the property of the solid form from the influence of particle size and formulation.
Full profiles under compendial and non-compendial conditions, with apparatus and media selected for discriminatory power.
Fed and fasted state simulated media, to approximate the conditions the drug will actually meet rather than the conditions that are easiest to control.
For enabled formulations and amorphous dispersions, how much supersaturation is generated and how long it survives before precipitation.
Side-by-side comparison of prototype formulations under identical conditions, for preclinical selection.
Method design comes before measurement, because a study built on the wrong method produces data that cannot be rescued by analysis.
We establish what the study has to decide — which form, which formulation, whether a change matters — since that determines the apparatus, media and sampling design.
The form of every sample is confirmed by diffraction before testing, and the residual solid is re-checked afterwards for conversion during the experiment.
Media, pH, surfactant and apparatus are selected for discriminatory power, using flow-through where sink conditions or media change are required.
Conditions are optimised until the method distinguishes the samples on the property of interest, and the analytical finish is validated for the concentration range.
Studies are run with the replication the comparison requires, under controlled temperature and hydrodynamics.
Profiles are compared statistically where appropriate, and interpreted alongside the solid-state data rather than in isolation.
A detailed technical-scientific report covering method rationale, raw data, profiles and conclusions.
The dissolution laboratory is equipped for both compendial testing and the non-standard experiments that development work actually needs.
The deliverable is a detailed technical-scientific report in which the method rationale is documented as carefully as the results.
That depends on what the study has to decide. A compendial method is appropriate for release testing; form selection and formulation comparison usually need a method developed for discriminatory power, sometimes with a flow-through cell. We would propose and justify the design rather than default to apparatus 2.
Yes, routinely. A form that converts in the dissolution medium will give a profile that belongs to a different solid than the one you submitted, so the residual solid is recovered and re-analysed. It is a step that is often skipped and frequently decisive.
Yes. Fed and fasted state simulated media are used where the objective is to approximate in vivo behaviour, particularly for poorly soluble candidates and enabled formulations.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
Turnaround depends on the techniques involved, the number of samples and whether methods already exist. We agree the timeline with you when the work is scoped, and tell you early if anything threatens it.
It depends on the techniques involved and on how many determinations are required. We confirm the exact quantity when we scope the work, and design the analytical plan around the material you have.
A detailed technical-scientific report with the methods used, the raw data, the results and their interpretation, suitable for inclusion in development and regulatory documentation.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours and are never shared or reused.
Tell us what you need to distinguish. We will propose the method, the media and the replication that will actually distinguish it.