路博润生命科学健康的健康)行业性zes in pharmaceutical partnership and helping clients from idea to execution by providing best-in-class excipients for pharmaceutical and over-the-counter products. When you partner with LLS Health, you benefit from working with us at every stage in the development process, with the ultimate goal of creating solutions that improve patient lives.
LLS Health is one of the world’s largest manufacturer of pharmaceutical grade carbomers, polycarbophil, and thermoplastic polyurethanes and has been manufacturing pharmaceutical excipients for more than 35 years. OurCarbopol®andPemulen™ polymers,Noveon® polycarbophilandApinovex™are excipients of acrylic acid, chemically crosslinked with polyalkenyl alcohols or divinyl glycol. These polymers have been successfully formulated into a variety of commercial products, including topicals, oral suspensions and solutions, bioadhesive applications, oral care applications and swallowable (peroral), chewable, buccal, and sublingual tablets.
路博润公司与所有相关监管机构to establish and maintain the global pharmacopeial status of its pharmaceutical ingredients. In addition, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and Europe.
Since their creation as the first commercial carbomers nearly 60 years ago, Lubrizol’sCarbopol® polymershave continued to be the highest quality carbomers on the market. Utilized in pharmaceutical products as rheology modifiers, tablet binders, suspension stabilizers, extended release polymers, mucoadhesive aids, and bioavailability enhancers, Carbopol polymers are well known for their versatility and ease of use as pharmaceutical excipients. Products within the Carbopol polymer family are chemically similar in that they are all high molecular weight, crosslinked polyacrylic acid polymers. However, these gel forming polymers differ by their chemical crosslinking and can be grouped into the following categories.
- Carbopol homopolymers: acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol
- Carbopol copolymers: acrylic acid and C10-C30 alkyl acrylate crosslinked with allyl pentaerythritol
- Carbopol interpolymers: carbomer homopolymer or copolymer that contains a block copolymer of polyethylene glycol and a long chain alkyl acid ester
We have made numerous enhancements to the Carbopol polymer family over time to help address regulatory demands, increase product robustness, and improve product handling, including, when mixing or processing Carbopol, ease of polymer dispersion to cut down on processing time. As part of these enhancements, our polyacrylic acid polymers are synthesized to meet the highest standards of safety. “Traditional” carbomers are synthesized in benzene, a substance that is increasingly restricted for use in pharmaceutical excipient applications. Our “toxicologically preferred” carbomers are synthesized in either ethyl acetate or a cosolvent mixture of ethyl acetate and cyclohexane, which are the products we now recommend for all new drug development projects.
In addition to our traditional excipients, LLS Health has added newer innovations to the Carbopol family in recent years, such as:
- Carbopol Ultrez polymers provide self-wetting capabilities for polymer dispersion that does not require mixing, enabling greater ease of use in formulating and processing.
- Carbopol 71G NF is the only granular carbomer available for direct compression formulations, providing increased versatility in the manufacture of oral solid dose products
- Carbopol ETD 2020 NF is designed to provide increased electrolyte tolerance in drug formulations.
Pemulen高分子乳化剂高分子量有限公司polymers of acrylic acid and C10-C30 alkyl acrylate crosslinked with allyl pentaerythritol. These pharmaceutical excipients provide effective emulsification properties to form stable oil-in-water emulsions. Pemulen polymer excipients contain both hydrophilic and hydrophobic portions and serve as excellent gel forming polymers, creating a network around suspended oil droplets and providing exceptional emulsion stability, often without the need for additional surfactants.
These pharmaceutical excipient emulsifiers are ideal for use in topical drug delivery, transdermal drug delivery, and other mucosal applications, such as ophthalmic drug delivery. Pemulen polymers help create low irritancy creams and lotions, providing optimal aesthetics, feel, and drug penetration into the membrane, as well as efficacious, non-irritating emulsion eye drops. Pemulen acrylic acid polymer excipients also provide viscosity building and high yield value to allow for suspension and stabilization of insoluble particulates.
Noveon® AA-1 Polycarbophil, USP is a high molecular weight acrylic acid polymer crosslinked with divinyl glycol. This polymer serves as an excellent mucoadhesive excipient and has been used extensively to enhance the delivery of active ingredients to various mucous membranes. Noveon Polycarbophil can provide enhanced lubrication functionality to ophthalmic drug formulations and excellent controlled release characteristics in oral drug delivery applications. This acrylic acid excipient is also ideal for use in, buccal, nasal, vaginal, and rectal bioadhesive products and is effective for use in both aqueous and anhydrous systems.
Apinovex™polymers are solubility-enhancing excipients for amorphous solid dispersions. Lubrizol’s Apinovex™ polymers are high molecular weight polyacrylic acid excipients designed to provide both processing and formulation benefits for spray-dried amorphous solid dispersions (ASDs). Apinovex polymers enable formulators to enhance the solubility of BCS Class II and IV APIs and develop more efficient oral dosage forms with high, stable drug loading.
Enhance Oral Solubility with Apinovex™ Polymers
- High, stable drug loading (up to 80%) via spray drying.
- Significantly improved drug release profile compared to crystalline APIs.
- Enables IP protection and 505(b)(2) formulations/lifecycle management.
IID Listed Ingredients
In addition to our traditional Carbopol®, Noveon®, Apinovex™and Pemulen™IID-listed polymers that can help improve the feel and performance of your topical pharmaceutical formulations our portfolio also includes emollients, humectants, emulsifiers, and surfactant thickeners.
Fast Facts about Lubrizol:
The Lubrizol Corporation, a Berkshire Hathaway company, is committed to enabling a sustainable future. Our unmatched science unlocks immense possibilities at the molecular level, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better. Our solutions are used by people every day, improving billions of lives around the world.
- 8800 Employees Worldwide
- 100+ Facilities
- 100+ Countries
Half of the world’s consumers use at least one of the products produced by our Advanced Materials segment. Our materials improve the performance, compatibility, reliability, and efficacy in products around the globe.
When you partner with Lubrizol Life Science Health (LLS Health), our team works with you through every stage of the development process. We specialize in helping clients from idea to execution by offering innovative polymers and excipients, as well as best-in-class contract manufacturing services. Our long history of polymer expertise and continued investment in research and manufacturing means we offer you and your customers a smooth and streamlined approach to innovative healthcare solutions.
History of Expertise
LLS Health is one of the world’s largest manufacturer of pharmaceutical grade carbomers, polycarbophil, and thermoplastic polyurethanes (TPU), and has been manufacturing pharmaceutical excipients for more than 35 years.
Global Reach & Superior Technical Support
The Lubrizol Corporation, a Berkshire Hathaway company, is a worldwide organization with an extensive infrastructure composed of global manufacturing, supply chains, and technical services. Our global presence links you to more opportunities by supporting growth in emerging markets, maintaining global supply and support, and understanding international regulatory requirements. We support our customers with technical centers around the world and knowledgeable technical solutions staff.
Compliant & Safe Materials
Lubrizol’s pharmaceutical-grade polymers are manufactured according to cGMP standards in ISO 9001 certified facilities. We work with all relevant regulatory bodies to establish and maintain the global pharmacopeial status of our pharmaceutical ingredients. Lubrizol excipients are listed in monographs of the international compendia for the US, Japan, Europe, China, and India. Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the US and Europe.
- Lubrizol Life Science – Pharmaceutical Polymers Typical Properties and Specifications
- Lubrizol Life Science – Pharmaceutical Excipients and Medical Device Polymer Overview
- Lubrizol Life Science – Excipients for Liquid and Semisolid Dosage Forms
- Lubrizol Life Science – Carbopol Formulation and Processing Guide for Oral Solid Dosage Forms
- Lubrizol Life Science – IID-Listed Ingredients for Topical Drug Delivery
- Lubrizol Life Science – Topical Drug Delivery Sell Sheet
- Lubrizol Life Science – Oral Drug Delivery Sell Sheet
- Lubrizol Life Science – Oral Care Sell Sheet
- Lubrizol Life Science – Not All Carbomers Are Equal
- Lubrizol Life Science – Pharmaceutical Excipients Guide
- Lubrizol Life Science – The LLS Health Abbreviated Excipient Guide