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On March 7, 2022, China’s CDE released a Notice on Public Solicitation of Questions and Answers (Draft for Comments) on the Study Conditions of Dissolution Curves in the Technical Guidelines for the Study of Pharmaceutical Changes of Marketed Chemical Drugs (Trial Implementation).
Providing referenceable technical specifications for clinical pharmacokinetic research of therapeutic protein drugs – CDE issues a notice on public consultation with the Guidelines for Clinical Pharmacokinetic Research of Therapeutic Protein Drugs (Draft for Comments).
The Study Conditions for Dissolution Profiles of Common Oral Solid Dissolution Forms are:
The dissolution medium selected:
It is recommended to study in at least three dissolution media (pH 1.2, pH 4.5, pH 6.8). If the standard medium (refers to the medium used in the registration standard) is different from the above media, the dissolution profile study in the standard medium needs to be added. For drugs whose solubility is strongly influenced by pH, it may also be necessary to investigate in more pH dissolution media.
Select the device and rotation speed:
It is recommended to use the basket method with a rotation speed of 100 rpm or paddle method with a rotation speed of 50 rpm. If a high variability or accumulation effect is observed at 50 rpm in the paddle method, the basket method of 100 rpm is recommended. Other methods may also be considered if adequately justified.
Select the volume, temperature, number of samples of dissolution medium:
It is recommended that the volume of the dissolution medium be 900 mL or less (the volume selected by the registration criteria is recommended), the temperature of the dissolution medium is 37 ± 0.5 °C, and at least 12 drug product units should be used for each dissolution profile determination.
How a drug with a strength-dependent dissolution profile be compared for different strengths?
If it can be demonstrated that this result is only related to the intrinsic solubility of the drug substance and not related to the formulation and process of the drug product, the dissolution profiles can be compared at the same dose.
The Dissolution medium of enteric-coated drug products:
In addition to the sampling points and the dissolution medium of enteric-coated preparations, it is recommended to refer to the above-mentioned study conditions and similarity evaluation methods for common oral solid dosage forms, and to study in combination with product characteristics.
It is recommended to investigate the drug release in hydrochloric acid pH 1.2 for 2 hours before transferring to pH 6.8 buffer. In addition, it is recommended to investigate the release in pH 4.5 medium. If the standard medium is different from the above media, the dissolution profile study in the standard medium needs to be added.
Sampling Points for Extended and controlled release formulas :
For extended and controlled release formulations, it is recommended to select representative sampling points, such as sampling at 1, 2, 4 hours (or suitable sampling points may be selected according to product characteristics), sampling every 2 hours after 4 hours, or other suitable time intervals until more than 80% drug release or dissolution plateau is reached.
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In China, a Clinical Trial Application (CTA) should be submitted to the National Medical Products Administration (NMPA), to request the authorization to administer an Investigational Drug to humans
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