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Excipients for Drug Formulation
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Excipients for Drug Formulation
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Excipients for Drug Formulation

Effective solubilization in
solid & liquid dosage forms.

Global
Excipients for Drug Formulation

Solubilization of poorly soluble active ingredients

Effective solubilization in solid & liquid dosage forms. The right path for greater solubility and bioavailability.

Poorly soluble drugs are one of the major challenges pharmaceutical manufacturers are facing. More and more drugs in development exhibit low solubility. At BASF, we offer a comprehensive range of cutting-edge solubilization polymers, and have an unparalleled understanding of the corresponding process technologies. This unique combination means that we can make sure you achieve effective solubilization across a range of dosage forms – particularly in solid dispersions.

Furthermore, BASF is a highly successful pioneer in the application of hot-melt extrusion technology in pharmaceutical production, which helps you combine effectiveness with cost efficiency.

Finding the best solubilization solution

Selecting the right solubilization product and technology for a poorly soluble API often involves a lot of trial and error. But partnering with our experts, you can tap into their extensive solubilization expertise and experience with all key technologies, such as hot-melt extrusion, spray drying, and drug layering. Our experts have access to industry-leading tools such as our high-throughput screening (HTS) robot. This puts them in an excellent position to help customers tackle their solubilization and bioavailability challenges rapidly and efficiently.

BASF delivers answers to even the toughest solubilization challenges

  • Comprehensive functional portfolio for solubiliation in solid & liquid dosage forms
  • Innovative excipients for poorly soluble APIs
  • Proven performance and safety
  • Technology leader for key technologies such as hot-melt extrusion
  • High throughput screening service Solu-HTS

Choose Your Drug Delivery System

Solid dispersions – a great way to increase the solubility and bioavailability of your drug

Liquid dispersions, solutions, emulsions & micro emulsions

NEW - Excipients for Parenteral Use

The parenteral application requires excipients of highest quality standards. Solubilizers and co-solvents are the most widely employed excipients in the formulation of parenterals. BASF offers a wide range of high-quality solubilization excipients and has unparalleled experience in quality and regulatory affairs, as well as solubility enhancement strategies.

Discover our solubilization solutions

Solubilization challenges need new ways

In the Pharmaceutical industry, more than 70% of new drugs developed are poorly water soluble, which means that the human body can hardly adsorb them. This represents one of the major challenges of the industry.

Role of Excipients in Amorphous Solid Dispersions

Dr. Frank Romanski speaks about the the role of excipient selection and key characteristics in amorphous solid dispersions at the BASF Solubilization Symposium in Ludwigshafen, Germany.

Drug Development Challenges

What are key challenges facing the pharmaceutical industry in terms of drug delivery? See Dr. Karl Kolter speaking with Pharmtech about an increasing number of poorly soluble drugs, poor bioavailability and the need for new excipient developments.

Innovation in Solubilization: Quo vadis?

“What cannot be dissolved, cannot be absorbed and cannot cure.” Dr. Karl Kolter from BASF Pharma Solutions spoke about the need of innovation at BASF’s Solubilization Symposium in October. Learn more about what formulators can do to achieve a higher solubility, the future of excipient development we might see down the road and why the Venus de Milo is much more soluble in water than many other pharma actives.

Excipients and Solubilization

There are a lot of excipients on the market – but are there already enough to address current and upcoming formulation challenges? Dr. Ferdinand Brandl about the need of innovation and new developments in the excipients field.

Choosing the right Solubilization Technology

Formulators can choose between many ways to achieve a higher solubility. With different solubilization technologies available, there is no “one size, fits all” solution. Dr. Karl Kolter explains how to decide which technology is most appropriate.

The need for novel surfactants

With different classes of surfactant available for solubilization, there are also further applications beyond solubilization. Dr. Karl Kolter explains possible areas like protein stabilization, antibody formulation or targeting molecules and why there is a need for novel surfactants.

Excipients selection for amorphous solid dispersions

For Dr. Frank Romanski, it is important to understand that solid amorphous dispersions are an “unique and elegant type of system” – the drug is fully solubilized within the polymer matrix. But this makes the right interaction of the API itself in the polymer system critical Learn more on the key features to achieve a stable solid amorphous dispersion.

API Supersaturation and Bioavailability Enhancement

“Supersaturation is a way to get drugs absorbed that would not be absorbed by just looking at their saturation solubility”- Dr. Ferdinand Brandl speaks about keeping your API in supersaturation and why poor solubility of drugs is a problem.

Impact of Matrix Polymers

Take a look at the key matrix polymer properties: In improving the physical stability of systems, you tend to decrease the chemical stability of formulations. Is it possible to strike a good balance in this challenging interplay? Dr. Frank Romanski explains how using more surfactants and solubilizers helps to maintain chemical stability.

Opportunities for early-stage drug development

Being very early in the drug development phase, you have to make decisions in terms of what kind of formulation do you want to go in. As an excipient provider, what we want to offer is options and easy testing methods – Frank Romanski presents opportunities in drug development.

Testing the Functionality of Solubility Approach

The complexity of testing: Is it enough to just analyze how much drug dissolves over time? It works fine for traditional formulations. But with more complex systems like amorphous solid dispersions, a different number of phases are present. Dr. Frank Romanski takes a deep dive together with Pharmtech on ways to test the functionality of solubility approaches.

What causes drug precipitation?

Supersaturating drug delivery systems can enhance bioavailability. However, supersaturating is the driving force of drug precipitation. Dr. Ferdinand Brand explains what causes drug precipitation and why this is a problem – and how formulators should address this issue.

Lipid-Based Drug Delivery Systems

Lipid-Based Drug Delivery Systems are challenging – how do you measure them? And how do you know how much drug is actually coming out? Learn more about drug delivery within these multifaced systems and why its variability affects formulation.

The importance of the structure activity relationship

Precipitation consists of two processes: Nucleation and crystal growth. Polymers can be used to inhibit nucleation and crystal growth rate, but the effectiveness of the polymer depends on the properties of the drug molecules. In this feature with Pharmtech, Dr. Ferdinand Brandl explains what this means for the importance of structure activity relationship.

Preparation Method and Amorphous Systems

The preparation method is crucial in solid amorphous systems. “It really matters how we prepare them – depending on the method we are using, we are landing somewhere else on the energy landscape.” In this feature with Pharmtech, Dr. Thomas Rades from University of Copenhagen explains different preparation methods and their consequences for the stability of amorphous systems.

In Conversation with Andreas Gryczke of BASF

The Medicine Maker's Charlotte Barker sat down with business leaders and specialists from across the pharmaceutical manufacturing landscape to discuss the latest innovations and trends. Here, Charlotte speaks with Andreas Gryczke from BASF.

Amorphous versus Co-Amorphous Systems

Not many people are familiar with Co-Amorphous Systems. What’s the difference to Amorphous Systems? And what are the advantages? Dr. Thomas Rades from University of Copenhagen gives an overview of the benefits in using small molecules instead of another polymer.

Using Lipid-Based Systems to Improve Solubility

Imagine someone is interested in developing a lipid-based drug delivery system. What are the key considerations and requirements? Dr. Annette Muellertz from Copenhagen University takes on this topic – and explains how supersaturating drugs might be interesting to reduce the excipient load.

Testing Lipid-Based Drug Delivery Systems Performance

There seems to be a lack of in-vitro/in-vivo correlation when working with lipid-based drug delivery systems (LBDDS). Dr. Annette Muellertz speaks about how to approach this issue and how you can test the performance of LBDDS.

Optimizing Lipid-based Drug Delivery Systems

Prof. Anette Müllertz, University of Copenhagen, speaks about the influence of drug load and composition when it comes to optimizing lipid-based drug delivery systems at the BASF Solubilization Symposium.

How to keep your API in supersaturation?

Dr. Ferdinand Brandl speaks at the BASF Solubilization Symposium about process of drug precipitation and different ways to inhibit precipitation. He also presents a new crystallization inhibitor from a BASF research project.

Drug Delivery from Multiphase Systems

At the BASF Solubilization Symposium Dr. Frank Romanski speaks about poorly water-soluble drugs, solubilization techniques, lipid complexity and the need for surfactants.

Biorelevant Dissolution Tests

At the BASF Solubilization Symposium Dr. Frank Romanski talks about biorelevant dissolution tests and factors that influence supersaturation and precipitation.

Overcoming Solubility Challenges

In the Thought-Leadership Series on Solubilization with Pharmaceutical Technology Rita Peters and Nigel Langley discuss how to overcome solubility challenges.

Common Formulation Challenges

At the annual Meeting of The American Association of Pharmaceutical Scientists (AAPS) Rita Peters and Nigel Langley talk about solubilization challenges in common formulation.

Facilitating Innovation

At the annual Meeting of The American Association of Pharmaceutical Scientists (AAPS) Rita Peters and Nigel Langley talk about how to facilitate innovation in the pharma industry.

Nano-FTIR as characterization tool for ASD

At the BASF Symposium Dr. Tobias Reinhard Umbach talks about how Nano-FTIR is used as characterization tool for amorphous solid dispersions (ASD).

Stabilizing Amorphous Drugs

Prof. Thomas Rades, University of Copenhagen, talks about polymers and small molecules in the process of stabilizing amorphous drugs at the BASF Solubilization Symposium.

Learn more about our solubilization solutions

Self-emulsifying Drug Delivery System (SEDDS) Formulary

Self-emulsifying Drug Delivery System (SEDDS) Formulary

Download Center

Looking for application guides, technical and scientific posters, brochures or technical Information? Visist our download Center.

Product Overview

Focusing on your needs with platform solutions

Webinar

Unlock the full potential of poorly soluble drug using ready-to-use SEDDS compositions & Introducing superSNEDDS – as way of increasing the applicability of lipid-based drug delivery systems

Webinar

Discovery, Formulation, and Performance of Self-Emulsifying Drug Delivery Systems (SEDDS) 

ebook

Current Solubilization Techniques: Insights from the BASF Solubilization Symposium

ebook

Formulation Technologies and Excipient Selection: Strategies for Improving Solubility

eBook

The Science of Insolubility: Experts come together to discuss the chemistry of solubility – and the solutions of the future

eBook

The Formulation Complex: Unravelling the challenges and trends in formulation best practice – and why lipids and softgels are leading the way.

Webinar

Practical Considerations for Overcoming Bioavailability Challenges with LBDDS ...

Webinar

Choosing the Proper Dissolution Method When Testing Solubilization Performance

Webinar

Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

Podcast

Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

Webinar

How glass-forming polymers improve bioavailability / Enhanced oral bioavailability with Soluplus® – case study

The Medicine Maker

From Brick Dust to Blockbuster? - Self-emulsifying lipids, and other innovative solubilizers and polymers

Drug Development & Delivery

SPECIAL FEATURE - Improving Bioavailability & Solubility: A Top-Down Versus Bottom-Up Approach

European Journal of Pharmaceutics and Biopharmaceutics

Micro-scale prediction method for API-solubility in polymeric matrices

Pharmaceutical Technology

The advantages and disadvantages of hot-melt extrusion in solid dispersion formulations

Drug Development & Delivery

EXCIPIENT UPDATE - Soluplus®: An Understanding of Supersaturation From Amorphous Solid Dispersions

American Pharmaceutical Review

Challenges and Opportunities in Oral Formulation Development

Our Highlight Products

Kollicoat® IR

As instant release film former, Kollicoat® IR combines exceptional coating quality with simple, robust processing. As wet binder, it combines powerful binding with no peroxides at all. And all those characteristics also make it a great pore former for sustained release formulations.

Kollicoat® MAE 100 P

Enteric coating with release above pH 5.5, coming as partially pre-neutralized powder saving you the neutralization step.

Kollicoat® Protect

Effective and reliable moisture protection for your active ingredients

Kollicream® 3C

A mild, emollient, solubilizer and skin penetration enhancer for dermal applications.

Kollicream® CP 15

A high viscosity, waxy emollient for dermal applications.

Kollicream® DO

A medium spreading emollient and solubilizer for lipophilic APIs.

Kollicream® IPM

A fast spreading emollient with broad penetration enhancement properties for lipophilic APIs.

Kollicream® OA

A medium spreading emollient with penetration enhancement properties, and a potential solvent for lipophilic solvents.

Kollicream® OD

A medium spreading non-ester emollient which is stable against acid and base hydrolysis and provides good skin penetration.

Kollidon® 12 PF

Low-molecular grade Kollidon®, intended for use as solubilizing agent, dispersant and crystallization inhibitor particularly for injectables. In addition applicable as pore former in solid dosage forms and viscosity enhancer in parenterals.

Kollidon® 17 PF

Low-molecular grade Kollidon®, intended for use as solubilizing agent, dispersant and crystallization inhibitor, particularly for injectables. In addition applicable as pore former in solid dosage forms and viscosity enhancer in parenterals.

Kollidon® 25

Our medium-molecular povidone is used in endless ways in pharmaceutical formulations - as binder, pore former, stabilizer, thickener, as solubilizing agent, crystallization inhibitor and many more. And with our trusted quality, it will always serve exactly what you intended it for.

Kollidon® 30

Our medium-molecular povidone is used in endless ways in pharmaceutical formulations - as binder, pore former, stabilizer, thickener, as solubilizing agent, crystallization inhibitor and many more. And with our trusted quality, it will always serve exactly what you intended it for.

Kollidon® 30 LP

Our original, Kollidon® 30 in a low peroxide version - protecting your oxygen-sensitive active ingredient longer.

Kollidon® 90 F

A highly effective binder, for use as a stabilizer in oral and topical suspensions, as a thickener, and as a hydrophilizing agent or pore-forming agent in medical plastics.

Kollidon® CL-M

Kollidon® CL-M is used as a stabilizer for oral and topical suspensions and to improve the drug release characteristics of tablets, capsules or granules. Our disintegrant with micronized particles, delivers a slight disintegration functionality when used as binder. The crosspovidone is also used as pore former in some formulations.

Kollidon® SR

Direct Compression Sustained Release

Kollidon® VA64

Kollidon® VA64 is used in granulation and as a dry binder in tablets, capsules and granules, as a film-forming agent in tablet coatings and subcoatings, and as a film-forming agent in topical sprays. Soluble copovidone widely used for instant release formulation and is suitable in hot-melt extrusion processes.

Kolliphor® CS 12

A non-ionic emulsifier; stable with acidic, basic and ionic excipients.

Kolliphor® CS 20

A non-ionic emulsifier with good sensory properties; stable with acidic, basic and ionic excipients.

Kolliphor® CS A

An easy-to-use, self-bodying cream base.

Kolliphor® EL

BASF's non-ionic solubilizer and emulsifier for the production of semi-solid and liquid formulations of water-insoluble actives and other hydrophobic compounds.

Kolliphor® ELP

Kolliphor® ELP is a non-ionic oil-in-water emulsifier and/or solubilizer for sensitive active ingredients

Kolliphor® HS 15

A potent nonionic solubilizer

Kolliphor® P188

Flexible excipient to overcome a wide range of pharmaceutical challenges that provide formulators with increased efficiency and added functionality.

Kolliphor® P 338

A polymeric multi-talent suitable for a large variety of applications, i.e. Kolliphor® P 338 can be used as solubilizer, emulsifier and plasticizer.

Kolliphor® P 407

A polymeric multi-talent suitable for a large variety of applications, i.e. as thickening agent and gel former and as a co-emulsifier and viscosity enhancer in creams and liquid emulsions.

Kolliphor® PS 20

Kolliphor® PS 20 is a non-ionic, hydrophilic emulsifier, co-emulsifier and solubilizer for pharmaceutical preparations like emulsions and creams, gels and foams as well as softgels.

Kolliphor® PS 60

Kolliphor® PS 60 is used as an emulsifier or co-emulsifier in topical pharmaceutical applications like creams and lotions and as non-ionic solubilizer in solid, semi-solid and liquid dosage forms or as foam stabilizer.

Kolliphor® PS 80

Kolliphor® PS 80 is a non-ionic, hydrophilic emulsifier, co-emulsifier and solubilizer for pharmaceutical preparations like like emulsions and creams, gels and foams as well as softgels.

Kolliphor® RH40

Non-ionic oil-in-water solubilizer and emulsifying agent

Kolliphor® SLS

a widely used ionic solubilizer & and high HLB anionic emulsifier that is suitable for application in liquid dispersions, solutions, emulsions and micro emulsions to formulate tablets, foams and semi-solids such as creams, lotions and gels

Kollisolv® GTA

A hydrophilic plasticizer used in both, aqueous and solvent-based polymeric coating of capsules, tablets and granules. Also used as a solubilizer and solvent as well as a humectant.

Kollisolv® MCT 70

Medium chain triglyceride compatible with fat-soluble vitamins, actives and essential oils

Kollisolv® P 124

The only monographed poloxamer that is liquid at room temperature – making it ideal for liquid dosage forms. It is used for liquid-filled softgel capsules as a dispersion medium for APIs, or as plasticizer for tablet formulations.

Kollisolv® PEG 300

Excellent solvents for a large number of substances that do not readily dissolve in water

Kollisolv® PEG 400

Excellent solvents for a large number of substances that do not readily dissolve in water

Kollisolv® PG

Manufactured under cGMP, Kollisolv® PG (1,2-propyleneglycol) can used across a wide range of applications, i.e. as plasticizer, solvent or co-solvent, stabilizer, or as carrier for emulsifiers.

Kollisolv® PYR

Solvent for injectables and oral formulations for animal health.

Kolliwax® CSA 50

A fatty alcohol mixture, preferred for its stability in emulsion formulations.

Kolliwax® GMS II

A solvent for oral, topical applications, co-emulsifier and low HLB surfactant, structure-building consistency factor for semi-solids and a viscosity enhancer. It also hardens suppository formulations and adjust their melting points.

Kolliwax® S

Kolliwax® S can be used for various oral solid as well as semi-solid dosage forms. Kolliwax® S can be used as a lubricant in oral dosage forms, matrix forming agent in sustained-release dosage forms, emulsifying and solubilizing agent in topical formulations and hardening agent in glycerin suppositories.

Kolliwax® SA

As lipophilic lubricant Kolliwax® SA is the first choice for sensitive acidic APIs. It is commonly also used as viscosity regulator for oil-in-water emulsions and as a pH independent sustained release agent. Kolliwax® SA acts as a plasticizer with included consistency factor in solid dispersions. It hardens suppository formulations and adjust their melting points.

Soluplus®

With its excellent capability to form solid solutions, Soluplus® is suitable for innovative processing technologies, such as hot melt extrusion. Soluplus® was awarded with the CPhI Silver Innovation Award in 2010.

Discover key technologies to increase bioavailability and our specific functional offer.

Crystallization Inhibition

Crystallization inhibition is an important factor to maintain drug solubility and bioavailability out of solid and liquid dosage forms in particular. BASF offers a range of well established crystallization inhibitors that ensure that your drug will not get lost on its way to the point of action in the body.

Hot Melt Extrusion

Hot-melt extrusion has been used in the plastics & food industries for decades. In the 1980s, BASF became the first company to apply it to the production of pharmaceuticals for enhancing the solubility and bioavailability of poorly soluble actives. Today, HME is an accepted process for creating solid dispersions of APIs.

Melt Granulation

Melt granulation is a great process option in a formulators' biovailability enhancement arsenal. A meltable binder is used to agglomerate drug and other ingredients to reduce recrystallization potential through separation. BASF offer all functional materials required for a successful formulation using melt granulation.

Spray Drying

Spray drying is an established technology in the pharmaceutical industry to create amorphous, soluble forms of active ingredients. Key for a successful process is the use of the right functional polymer to ensure a stable solid dispersion. BASF offers a wide range of functional polymers to choose from, along with all other excipients typically used in the formulation.