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CDE issues a notice on the "Technical Guidelines for Pharmaceutical Research of Chemical Oral Soluble Film Agents (Draft for Comments)"
Date: 2024-09-10Read: 0
On August 26th, the Drug Evaluation Center of the National Medical Products Administration issued a notice to publicly solicit opinions on the "Technical Guidelines for Pharmaceutical Research of Chemical Drug Oral Soluble Film Agents (Draft for Comments)". The deadline for soliciting opinions is one month from the date of publication.
The draft for soliciting opinions mentions that the guiding principles are applicable to pharmaceutical research of new and generic oral film agents. Based on the characteristics of oral film agents,Emphasize the technical requirements for pharmaceutical research, including prescription and production process, quality research and control, stability research, packaging system, etcProvide technical guidance for the research and development of oral dissolving film agents.
And in the prescription and production process, quality research and quality control, dissolution rate and dissolution behavior are mentioned respectively.
Here is a case study of the dissolution test of oral solution film.
How to conduct dissolution experiments on oral dissolution films?
Oral Thin Films (OTF) is a novel oral drug delivery system. By placing the oral dissolution membrane directly on the tongue or other oral mucosal tissue, the membrane will be wetted by saliva, allowing drugs to quickly dissolve and release, promoting direct entry into the systemic circulation system and avoiding exposure to the gastrointestinal environment, thereby improving bioavailability.
In the dissolution test of oral dissolution film, one thing to note isThe key is how to fix the oral dissolution film and place it in the dissolution cup for experimentation.
Paddle method vs flow pool method
If using the basket method, the oral solution film can be directly loaded into the rotating basket; If using the paddle method, a sieve can be prepared to fix the oral dissolution film, and then it can sink to the bottom of the dissolution cup for dissolution.
This experimental scenario is quite ideal, but there may be some problems during the experiment, such as: the dissolution of the oral dissolution film is too fast, with 100% dissolution in 5 minutes, and a slower dissolution curve cannot be obtained; Using the paddle method for dissolution experiments, there may be a time difference in the administration time of 6 cups, which may affect the dissolution and result in unsatisfactory parallelism of the dissolution results.
Paddle method experiment:
Oral dissolution film dissolves 100% in 5 minutes, with RSD greater than 25%
Using the same oral dissolution membrane, conduct tests using both the paddle method and the flow cell method.
Flow pool method experiment:
The same oral dissolution film obtained a slow dissolution curve in the flow cell method, and both parallelism and repeatability met the requirements.
SOTAX CE 7smart
Flow pool dissolution testing system
From the above examples, it can be seen that there are certain advantages to using the flow cell method for the dissolution experiment of orally dissolved membrane samples. Due to the relatively mild fluid dynamics of the flow cell method, it can slow down the dissolution behavior of the orally dissolved membrane. The orally dissolved membrane is loaded in the flow cell, and the loading position is relatively fixed. The contact time between the dissolution medium and the orally dissolved membrane is also consistent, which can obtain a dissolution curve with good parallelism and slow dissolution. The design of its flow cell can be flexibly applied to various dosage forms, and due to its milder medium fluid dynamics, it is conducive to conducting dissolution experiments on rapidly releasing formulations such as oral dissolution membranes to obtain more accurate dissolution curves.