INHALATION DRUG DELIVERY VIDEOS

In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, describes the differences between the two concepts, including how they differently relate to considerations of risk.

Dry powder capsules offer a compact, portable means for patients to receive treatment. Examine the challenges of dry powder formulation and unlock the potential of high-dose inhaled medications.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

  • Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.