health care claims and capabilities · claims and . capabilities ... test on your api to determine...
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Claims and CapabilitiesHealth Care
Innovation you can build onTM
Your Full Spectrum Solution Provider
At Croda, we offer high quality ingredients and technical expertise to help our customers get the best performance from their active ingredients:
We value our close relationship with our customers and offer opportunities to collaborate with our teams to develop formulations and solutions to meet your challenges.
This brochure highlights the available expertise and capabilities for evaluating Croda raw materials in your formulations.
Full Spectrum Solution Provider
2013
High Quality Commitments
With key team members belonging to internationally recognised quality institutions, you can rest assured that the quality of our products
meet the highest standards.
Pioneering Dynamic and
Custom Solutions
With a broad internal chemistry set and a global team of experts, Croda is very well positioned to translate market insights to trusted solutions. We can
tailor these solutions to find one that best fits YOU!
High Quality
Commitments
Croda plays a leading role across internationally recognised quality and
regulatory institutions. You can rest assured that the quality of our products
meet the highest standards.
Extensive Global Reach
With 35 sales offices, 20 R&D facilities and 18 manufacturing sites
around the globe, Croda is always ready to meet your formulation support
and supply needs
Advancing Technology
Croda provides technology that helps you stay one step ahead,
providing you with ingredients that add value to your formulations, such as
our Super Refining technology and High Purity Omega 3 products
Our technical team can offer a range of support for pharmaceutical, skin health and veterinary applications.
We provide expert technical help to our customers in five important areas, ensuring that you achieve the best possible results from your formulations:
l Solubilityl Stabilityl Formulation developmentl Bioavailabilityl Sensory
Supporting our Customers
Quality by Design (QbD)
Innovation you can build onTM
Design Space
Market / Product / Customer Needs
Product / Process Research - R&D
C
omm
ercia
l Man
ufactu
re
Con
trol S
tra
tegy
Product Design Process Design
Knowledge Space
C
ontro
l Stra
tegy
Continual Improvment
Change Control
Croda QbD model
Croda manufactures its pharmaceutical excipients to the highest quality standards and QbD has been inherent in our systematic approach to manufacturing for many years.
Our extensive data set can be applied to establish the variability of key attributes to enable our customers to explore the parameters of the excipients which have an impact on their formulation.
We understand how the implementation of QbD may be complex, but Croda can help you make QbD activity much simpler and less costly and time consuming.
Our understanding of the variation of our excipients’ properties and how they relate to critical process parameters and product quality attributes, together with our robust and flexible manufacturing processes, ensure Croda are ready to support you with your QbD project goals.
Our Super RefinedTM and High Purity excipients go a long way to improving the stability of your API. Using state of the art analytical equipment, we are able to test the stability of your API alone, in solvent, or as part of a whole formulation.
Solubility of Active Pharmaceutical Ingredients (APIs) can be a challenge for pharmaceutical Formulators. Let us help you to develop a high quality formulation by carrying out a solubility test on your API to determine its maximum solubility in a range of Croda excipients.
Visit www.crodahealthcare.com to see our Solubility Guide for instant help with formulating with a range of APIs.
Solubility
Stability
2013
Solubility Guide
For more information on any of the products mentioned in this brochure, please contact your sales representative or visit our website
www.crodahealthcare.com
As API solubility continues to present challenges for the
pharmaceutical formulator, Croda has determined the solubility
of a range of actives in a number of Croda’s high purity
excipients. This baseline of information can provide you, the
scientist, with a clearer starting point for your development work.
Within this chart, the solubility of 12 drug actives was determined
using a range of Croda excipients for the purpose of demonstrating
their capabilities to solubilise APIs. The lipophilic pharmaceutical
actives, listed in order of lowest to highest logP values, were
selected from Class II of the BCS classification system.
Total solubility of the selected drug actives were determined in
the listed excipients and the appropriate solubility descriptors
were applied using FDA recommended guidelines.
% Drug Recovery Key:
Very Soluble 50.00-100%
Freely Soluble 10.00-49.90%
Soluble 3.30-9.90%
Sparingly Soluble 1.00-3.20%
Slightly Soluble 0.10-0.90%
Very Slightly Soluble 0.01-0.09%
Practically Insoluble <0.01%
DRUG ACTIVE
Product Names Chemical Description HLB Value Tenoxicam Glipizide Griseofulvin Phenytoin Gliclazide Spironolactone Estradiol Haloperidol Mefenamic Acid Flufenamic Acid Fenofibrate Clofazimine
Polar Excipients
Crodasol™ HS HP PEG-660 12-Hydroxystearate 15 Slightly Soluble Slightly Soluble Sparingly Soluble Sparingly Soluble Slightly Soluble Sparingly Soluble Sparingly Soluble Sparingly Soluble Slightly Soluble Freely Soluble Soluble Sparingly Soluble
Glycerox™ 767HCPEG-6 Caprylic/Capric
Glycerides14.1* Slightly Soluble Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Sparingly Soluble Freely Soluble Soluble Sparingly Soluble
Super Refined™ Arlasolve™ DMI Dimethyl Isosorbide — Slightly Soluble Slightly Soluble Sparingly Soluble Soluble Sparingly Soluble Freely Soluble Soluble Sparingly Soluble Soluble Freely Soluble Freely Soluble Soluble
Super Refined™ Oleic Acid Oleic Acid1.0 Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Very Slightly Soluble Freely Soluble Slightly Soluble Soluble Soluble Freely Soluble
Super Refined™ PEG 300 Polyethylene Glycol 300 — Slightly Soluble Slightly Soluble Slightly Soluble Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Sparingly Soluble Freely Soluble Sparingly Soluble Slightly Soluble
Super Refined™ PEG 400 Polyethylene Glycol 400 — Slightly Soluble Slightly Soluble Slightly Soluble Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Sparingly Soluble Freely Soluble Sparingly Soluble Slightly Soluble
Super Refined™ Polysorbate 20 Polysorbate 20 16.7 Slightly Soluble Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Slightly Soluble Freely Soluble Soluble Slightly Soluble
Super Refined™ Propylene Glycol Propylene Glycol — Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Slightly Soluble Soluble Slightly Soluble Slightly Soluble
Tween™ 80 HPPolysorbate 80
15 Slightly Soluble Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble Sparingly Soluble Freely Soluble Soluble Sparingly Soluble
Non-Polar Excipients
Crodamol™ DADiisopropyl Adipate 9.0* Very Slightly Soluble Very Slightly Soluble Soluble Slightly Soluble -----
Soluble Slightly Soluble Slightly Soluble Slightly Soluble Soluble Freely Soluble Sparingly Soluble
Crodamol™ GTCC Medium-Chain Triglycerides 10.0* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Soluble Soluble Sparingly Soluble
Span™ 20 Sorbitan Monolaurate 8.6 Very Slightly Soluble Very Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Slightly Soluble Sparingly Soluble Soluble Sparingly Soluble Sparingly Soluble
Super Refined™ Corn Oil Corn Oil7.9* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Sparingly Soluble Slightly Soluble
Super Refined™ Cottonseed Oil Cottonseed Oil 7.9* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Practically Insoluble Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Sparingly Soluble Slightly Soluble
Super Refined™ Crodamol™ HL Hexyl Laurate8.0* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble ----- Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Soluble Soluble Slightly Soluble
Super Refined™ Crodamol™ IPM Isopropyl Myristate 10.0* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble ----- Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Soluble Soluble Slightly Soluble
Super Refined™ Crodamol™ IPP Isopropyl Palmitate 10.0* Practically Insoluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble ----- Slightly Soluble Slightly Soluble Slightly Soluble Slightly Soluble Soluble Soluble Slightly Soluble
Super Refined™ Crodamol™ OO Oleyl Oleate7.0* Practically Insoluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble ----- Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble
Super Refined™ Novol™ Oleyl Alcohol14.5 Very Slightly Soluble Practically Insoluble Very Slightly Soluble Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Slightly Soluble Slightly Soluble Soluble Sparingly Soluble Slightly Soluble
Super Refined™ Olive Oil Olive Oil7.7* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Practically Insoluble Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Sparingly Soluble Slightly Soluble
Super Refined™ Sesame Oil Sesame Oil7.8* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Practically Insoluble Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble
Super Refined™ Soybean Oil Soybean Oil7.7* Very Slightly Soluble Practically Insoluble Very Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Very Slightly Soluble Very Slightly Soluble Slightly Soluble Sparingly Soluble Soluble Slightly Soluble
Reference
Water **Water
— Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble Practically Insoluble
The key descriptions above are based on the % recovery of the APIs.
* Required HLB
** The water solubility of the specified actives is classified as it appears in the monograph for each active
LogP
= 1
.90
MW
= 3
37.4
g/m
ol
LogP
= 1
.90
MW
= 4
45.5
g/m
ol
LogP
= 2
.18
LogP
= 2
.47
LogP
= 2
.60
LogP
= 2
.78
LogP
= 4
.01
LogP
= 4
.30
LogP
= 5
.12
LogP
= 5
.25
LogP
= 5
.30
LogP
= 7
.66
MW
= 3
52.8
g/m
ol
MW
= 2
52.3
g/m
ol
MW
= 3
23.4
g/m
ol
MW
= 4
16.6
g/m
ol
MW
= 3
75.9
g/m
ol
MW
= 2
41.3
g/m
ol
MW
= 2
41.3
g/m
ol
MW
= 2
81.2
g/m
ol
MW
= 3
60.8
g/m
ol
MW
= 4
73.4
g/m
ol
SolubilityOPTIMIsING FORMULATION sUCCEss
For more information, please contact your sales representative
Non-warrantyThe information in this publication is believed to be accurate and is given
in good faith, but no representation or warranty as to its completeness or
accuracy is made. Suggestions for uses or applications are only opinions.
Users are responsible for determining the suitability of these products for their
own particular purpose. No representation or warranty, expressed or implied,
is made with respect to information or products including, without limitation,
warranties of merchantability, fitness for a particular purpose, non-infringement
of any third party patent or other intellectual property rights including, without
limit, copyright, trademark and designs. Any trademarks identified herein are
trademarks of the Croda group of companies.
©2016 Croda Europe Ltd
HTCP010V2
www.crodahealthcare.com North America [email protected], Middle East & Africa [email protected]
Latin America [email protected] Pacific [email protected]
Innovation you can build on™
Place active and excipient in a vial
Centrifuge through a 0.45 µm filter
Mix at 25˚C for 48 hours
Remove supernatant for HPLC
AU
Time (minutes)
Sesame Oil Containing Active at Time 0 Sesame Oil Containing Active After 28 Days
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0 1 2 3 4 5 6 7 8 9 10 11 12
Sesame Oil NF Super Refined Sesame NF-NP
AU
Time (minutes)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0 1 2 3 4 5 6 7 8 9 10 11 12
Sesame Oil NF Super Refined Sesame NF-NP
Using Croda’s range of high quality ingredients, our expert formulators are available to help you to meet your formulation needs for a variety of formulation types.
They can provide help in a number of areas including:
Formulation Development
Innovation you can build onTM
Pioneering dynamic and custom solutions. Our technical team also has the capability to develop new test methods to meet your specific needs.
Claims substantiation. Established test methods are employed to provide key data including formulation stability, rheology, counter-irritancy, barrier integrity, foaming characteristics and many more.
Provision of formulation guidelines for support when using Croda ingredients. Our formulation finder has over 80 example formulations - visit www.crodahealthcare.com to find out more!
Development of novel formulations, to give you the edge in the market. For example, our fast absorbing foam formulation utilising CrodafosTM MCK and CrodasinicTM LS30. This is a light topical formulation that leads to increased patient compliance.
Sensory is an important factor to consider to ensure patient compliance.
SensificationTM is an easy-to-use method which shows how the desired sensorial attributes can be achieved by selecting the correct emulsifier.
Visit www.crodahealthcare.com for more details and try out our Emulsifier Selector tool.
Our specially trained in-house sensory panel is also available to test your formulations and provide valuable feedback.
We have industry recognised test methods for determining the penetration of your API through a membrane.
We can offer help and advice when formulating with our excipients designed to improve bioavailability of an API.
Bioavailability
Sensory
Deliv
ery/
% A
pplie
d Do
se
Control With 10% Arlasolve DMI05
10
15
20
25
30
35
40
45
50 Tape Strips
Skin
Our technical team is available to give advice on all areas covered in this brochure.
Our experts are happy to offer formulating advice to help you achieve optimum solubilisation and delivery of your API, along with answering any other formulating or testing questions you may have.
Please speak to your local sales representative who can put you in touch with the technical team to find out what tailor made solutions we can provide. Contact Information can be found on the back page of this brochure.
Ask the Experts!
Innovation you can build onTM
Skin
Customer Academies Croda offer a Customer Academy designed for formulators, with the aim of building upon and advancing existing formulation knowledge.
Each Academy mixes theoretical learning with practical applications in the laboratory, giving our customers the opportunity to work with a wide range of products and learn how superior Croda excipients can be used to improve your formulating experience. Our in-house experts can also offer advice on how to optimise your formulations.
Customer feedback from the 2016 Formulation Strategies Academy
Content was well presented and relevant
“ “ “
“ “ “Perfect combination of theoretical and practical sessions
Both theoretical and practical parts were very useful and interesting
We have dedicated Sales Representatives in 35 countries around the globe.
Visit www.crodahealthcare.com to submit any queries you may have.
Alternatively, use one of the below email addresses to contact your local sales office:
Europe, Middle East & Africa: [email protected]
North America: [email protected]
Latin America: [email protected]
Asia Pacific: [email protected]
06/16 HYCMB006
Our website can be found at www.crodahealthcare.com. Here you can find a range of tools to help you, including our Product Finder, Emulsifier Selector, Formulation Library, Solubility Guides and much more.
You can also download product literature, see online seminars and watch helpful formulation videos.
Croda Direct
Contact Information