Posted by LLS Health Technical Team | 03/17/2023
The FDA 505(b)(2) regulatory pathway for drug approval, which allows applicants to use existing safety data as evidence, continues to grow in popularity.
Posted by Nicholas DiFranco | 01/25/2023
For drug developers working on oral solid dosage drug projects, solubility, and therefore bioavailability, is a significant challenge. At present, poor water solubility impacts around 40% of drugs currently on the market.
Posted by LLS Health Technical Team | 05/03/2022
Apisolex™ technology provides formulators with a safe, polyamino-acid-based excipient to enhance the solubility of BCS Class II and IV APIs, including oncology agents, for parenteral delivery.
Posted by LLS Health Technical Team | 04/14/2022
Oral solid dosage forms, such as tablets, represent the largest segment of the pharmaceutical market. Despite the long history of oral solids in pharmaceuticals, there is still high demand for innovation. For new oral drugs to be commercially successful, it is key that they are easy to manufacture, cost-effective, and patient-friendly. Excipient technologies, such as Carbopol® polymers, can enable for formulator- and patient-centric benefits for these products. Learn more in this article.
Posted by LLS Health Technical Team | 03/29/2022
Excipient-enabled approaches to solubility enhancement can accelerate drug development by leveraging established, scalable manufacturing techniques. In this post, we discuss common formulation tactics for BCS Class II and IV APIs and introduce Lubrizol’s novel solubility-enhancing excipients, oral-grade Apinovex™ polymer and injectable-grade Apisolex™ polymer.
Posted by LLS Health Technical Team | 02/01/2022
Whether your focus is in electrophysiology, neurovascular, structural heart, vascular peripheral intervention or specialized/localized drug delivery, working with a skilled design and development team helps you achieve desired design requirements on schedule and in budget.
Posted by LLS Health Technical Team | 01/31/2022
In this post Lubrizol Life Science Health explores the regulatory requirements governing excipient safety for the United States as an example of best practice to help formulators understand how to select the most appropriate carbomer for their needs.
Posted by LLS Health Technical Team | 01/11/2022
Lubrizol Life Science Health is committed to providing a single-source solution that supports customers from concept to commercialization for their medical device solutions. The recent expansion of our U.S. Medical Device Design Center represents the next phase of this commitment.
Posted by LLS Health Technical Team | 11/10/2021
OEMs and startups alike increasingly see the advantages of working with an integrated medical device development provider that can support projects from concept to commercialization.
Posted by LLS Health Technical Team | 10/26/2021
The need to consistently place the patient at the center of development and manufacturing decisions has been key in the pharma industry. Lubrizol Life Science Health explores the meaning of patient centricity and key considerations that pharmaceutical companies should bear in mind to ensure successful development of a truly patient-centric drug product.
Posted by LLS Health Technical Team | 10/25/2021
The EU Medical Device Regulation 2017/745 (MDR) that went into effect May 26, 2021, presents a number of challenges for medical device manufacturers, especially makers of implantable and invasive devices.
Posted by LLS Health Technical Team | 10/13/2021
The safety of a medical device is of utmost concern and importance at all times during its development, manufacturing, regulatory submission and use. One critical step in establishing the safety of a device is to evaluate how the device interacts with the body. Device makers’ materials suppliers may be helpful in conducting the evaluations at both the material and device levels.
Posted by LLS Health Technical Team | 10/07/2021
In this blog, we discuss key initial formulation considerations when designing mucoadhesive dosage forms, such as those involving the drug, inactive ingredients, and intended site of action.
Posted by LLS Health Technical Team | 08/24/2021
Every market has unique demands when it comes to the properties of oral care products. However, no matter the market, the ability to promote longer-lasting properties of oral care products will give a brand greater appeal in an increasingly saturated marketplace.
Posted by LLS Health Technical Team | 08/19/2021
To penetrate the markets, manufacturers must ensure that drug products comply with the local regulations. In an industry where the global regulatory environment is fragmented, developers and manufacturers need to know the standard of their carbomers.
Posted by LLS Health Technical Team | 08/05/2021
As much as 40-70% of new APIs are poorly water soluble, having negative implication for their effectiveness. To address this issue and ensure the successful commercialization of these products, solubility enhancement is essential. In our latest blog, we explore solubility enhancement techniques.
Posted by LLS Health Technical Team | 07/21/2021
A key factor in the success and effectiveness of many drug products is whether or not they are “mucoadhesive”. In this blog, we will explore four key ways mucoadhesion, when optimized, can improve over-the-counter (OTC) or prescription (Rx) drug products.
Posted by LLS Health Technical Team | 01/28/2021
While advancements in drug delivery are continually improving drug efficacy and bioavailability, there are still significant areas of unmet need in the market. This post discusses some key challenges of oral drug formulations and why they are important to address for patient health and differentiation in a crowded market. We uncover strategies for overcoming these challenges, including extended drug release, taste masking, and tablet size reduction.
Welcome to the Blog. Our mission is to accelerate your success through partnership and proactive innovation. This blog will provide unique perspectives from the best in the business. We are dedicated to sharing our extensive market knowledge and formulation expertise to help our partners improve patient outcomes.
