- Dr. Joël Richard, Head of Technical and Pharmaceutical Operations, MedinCell
- Dr. Kerstin Walke, Head Pharmaceutical Development Biologicals, Boehringer Ingelheim
• BEPO(R) technology presentation
• High versatility: key formulation parameters for controlling drug release
• Major advantages versus classical long-acting injectable technologies
• Prospectives in the field of Long Acting formulations of fragile molecules
• ICH Q3D and USP661.1 bring new requirements that could 'shake' the industry if not well prepared
• This regulation destroys the well-worn ‘food contact declarations are enough’
• Packaging supply chain will need to evaluate the impact of the new regulations
• USP661.1 taking full effect in May 2020, you might avoid to be ‘shaken’ into last-minute changes!
Today the standard measure for the chemical durability for parenteral packaging is based on the hydrolytic resistance test (ISO 4802; USP<660>; Ph.Eur 3.2.1) for which the vial is filled for testing to 90% of its brimful volume. However, nowadays an increasing amount of innovative drugs e.g. high-potent drugs will have a low filling volume. Consequently, the determined hydrolytic resistance might not represent the amount of leached glass elements for those volumes. This is attributed to two main contribution factors: One is an increasing ratio of the wetted surface to filled volume. The other contributing effect is an increased leaching tendency typically observed with borosilicate glass of the wetted wall near bottom area (especially when the standard manufacturing technology is applied).
The phenomenon itself will be explained and some analysis data will be presented.
For the Quantification of the contributing effects the amount of the representative leached glass elements boron, sodium and silicon after 24 weeks at 40°C for different fill volumes (0.5, 1.0 and 2 ml) with purified water and 15 % KCl-solution for 2 ml vials made from type I class B borosilicate- and from aluminosilicate glass were investigated.
The commonly established standard conversion process has been applied for both types of glass vials.
• Challenges in the development of parenteral containers for ophthalmic applications / intravitreal injections
• Polymer Syringe with plasma deposited barrier coating and silicone-oil free lubricity coating
• EO sterilization study to show no gas migration into drug product
• Low particles