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 | 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 | 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 | 10/07/2021
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.
