Early drug formation
19 important questions on Early drug formation
What is the EU definition of the pharmaceutical development?
In a short way: Helps to better understand the nature/ design of the product
- gives a scientific overview of the product
What kind of information is gathered during the pharmaceutical development?
- optimization (critical elements)
- verification studies
Actually you show that you are able to produce the drug according to the requirements.
What are the key elements in the preformulation?
- Small scale tests
- Time to evaluate results
- Reporting of results and conclusion with a focus on future dosage from development
- Communication of results to people involved in further development
- Threads to preformulation: No regulatory requirements, Costs, time and capacity.
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What are the characteristics of the solution?
- pH stability profile: degradation above pH 5.5
- effect of co-solvents
- sterilisation: no heat sterilisation possible
What are the characteristics of a solid?
- specific surface area: 1,5 M2/g (large)
- flow properties: poor
- compaction: poor binding properties
- contact angle: 77 degrees
- intrinsic dissolution rate: 1.5 ug/cm2/min
- polymorphism: no
- No thermal explosion risk
What are the characteristics of the development of the first clinical formulation?
- It is a choice for a composition and a process based on limited experimental work.
- It is a combined activity of dosage form development and analytical development
- limits are: time, amount of drug substance, wide range of dosage strength.
Where does the development of the first clinical formulation rely on?
- experience with the dosage form, scientific knowledge on the dosage form
- downscaling (types of apparatus) and bracketing
- qualified and skilled personnel.
- good science from preformulation and compatibility
What is the target product profile?!
What are the specifications of the clinical capsule?
What are prerequisites of a first clinical production?
- cleaning must be proper
- Documentation
What are potential problems in the first clinical production?
- changes in handling
- changes in equipment, scale and environment
- changes in dosage strength
- changes in drug substance
How is the prevention of problems?
- Use formulations and technology with which experience exists and on which scientific knowledge is available
- clear and concise protocols and instructions
- adequate communication
- realistic setting of specifications and IPC's based on previous development work and previous experience with similar products and processes
When to start with the clinical studies with the market formulation?
- after central clinical studies: more time for development, more information available at the start, limited scale up and validation of the clinical form.
How is the market formulation developed?
- Develop analytical methods
- Use the PAR approve (The proven acceptable range)
- Work at laboratory scale
- Re-define your requirements
How do you optimize the formulation and the process?
Why a 10% production scale is necessary?
What kind of validation/qualifications are there?
- installation qualification
- operational qualification (calibration
- process validation
- cleaning validation
How does the process validation flow-scheme go?
2) optimisation to find critical parameters
3) scale up
4) write validation protocol
5) review and approval (here it can also become rejected)
6) execution
7) analysis, data acquisition
8) reporting
9) data review (by a qualified person)
10)acceptance or rejection (big problem)
11) change control and revalidation
What are the reasons to apply GMP during development?
- To improve R&D operations
- To ensure integrity of data
- To increase the change for regulatory sucess
- To ensure integrity of toxicological and clinical data
- to improve the quality of the production
- to reduce the overall costs.
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