Extractables and Leachables Testing for inhaled medicines : (주)큐비디 INTERTEK 자료실

알림

🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐

At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:

🔍 Consultation on the current E&L study approach

🔬 Critical assessment and evaluation

📜 Extractables & Leachables study and profiling

🧪 Identification & Toxicological evaluations

🛡️ Risk and Safety assessments

✅ Regulatory Registration support

Key Areas of Expertise:

Container closure systems like glass vials, stoppers, and related products.
Single-use systems and process contact materials.
All types of Medical Devices.

"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:

FDA, EMA, CHINA, KOREA, JAPAN, BRASIL, Türkiye(Turkey) and more.

Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr

For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr

Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟

관리자

INTERTEK 자료실 Extractables Leachables

2019-07-22

Extractables and Leachables Testing for inhaled medicines

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.

Pharmaceutical Technology Europe JUNE 2017 PharmTech.com

Tino Otte

is senior consultant at Intertek,

tino.otte@intertek.com,

Tel: +41 (61) 686 48 56

Orally inhaled and nasal drug product (OINDP) formulations, which are primarily a propellant including an organic solvent, have a high potential for the leaching of substances from the delivery device components. In this context, a device such as a dry powder inhaler (DPI) or pressurized metered dose inhaler (pMDI) is considered a primary packaging material or a container closure system (CCS). An extractables and leachables (E&L) investigation should be conducted to guarantee that the pharmaceutical packaging system is safe and does not negatively influence the drug product.

Extractables are compounds that are released from a CCS into an extraction solution, which is typically a simulation solvent that mimics the drug formulation, during forced extraction experiments. Leachables are compounds that leach from a CCS into the drug formulation under normal storage conditions, such as those applied during a formal stability study.

Extractables are common, but not always the worst-case leachables; new reaction products formed from extractables and drug formulation components can also be considered as extractables. Leachables are drug product impurities that have the potential to affect patient safety.

For example, in a pMDI, precipitates were identified that were found to be polyaromatic hydrocarbons (PAHs), mercaptobenzothiazol, and N-nitrosamines originating from the rubber materials used for construction of the inhaler devices (1, 2). Other examples of potential leachables are isopropylthioxanthones, which are used as photoinitiation agents in inks, and N-nitrosamines, which originate from printing compounds. Both have also been found as contaminants in packaged food (2).

In general, additives and process chemicals that are present in packaging material are small molecules, and the propellants used in pMDIs are quite effective solvents for such molecules. In addition, there are many non-intentionally added substances, such as those derived from process chemicals and degradation products present in packaging materials, all of which may occur as later drug impurities. For this reason, a well-designed E&L study will help to avoid analytical surprises, mitigate risks associated with impurities, and help minimize costs if problems are identified late in the product development process.

379 0

PDMA Update (Modernization of USP Packaging Standards for Glass and Elastomeric Components ) Rubber stopper related special case compounds

목록 글쓰기