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Injectable

The formulation of parenteral and injectable dosage forms present unique challenges in comparison to other administration routes. Systemic administration offers advantages in terms of absorption and the elimination of first pass metabolism, but these are counterbalanced by the fact that parenteral formulation presents frequent challenges and limitations associated with drug stability and poor solubility. Excipient selection is based on drug compatibility and the minimum concentration of drug required to produce the targeted pharmacological effect. 
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Working together to deliver your API
  • Access specialised technical support to navigate your formulation development challenges
  • Broad range of high purity compendial excipients listed by the FDA Inactive Ingredients Guide as suitable for parenteral administration
  • Flexibility to develop specialised ingredients and formulation solutions supported by regulatory experience in new monograph development

Croda’s Super Refined products are a range of highly purified pharmaceutical excipients designed to reduce the risk of product degradation, improving the chances of successful formulation development. Super Refined polysorbates , PEGs, and oils add value to parenteral drug formulations by:

Reducing API costs 

We have formulated a number of APIs with our Super Refined excipients and found that in many cases a significantly higher percentage of API is retained over time compared to formulation with standard pharmaceutical grade excipients. This decreases the minimum efficient concentration required to produce the desired pharmacological effect over the shelf life of the product, therefore requiring less API per dose.

Improving product safety profiles

The removal of polar impurities reduces API/excipient interactions, thus minimising the presence of potentially problematic API degradation products.

Lengthening product shelf lives

Super Refined excipients have been demonstrated to outperform their standard pharmaceutical equivalents with regard to the stabilisation of certain APIs over significantly longer periods of time and also with regard to the oxidative stability of the excipient itself, which has an effect on the overall stability of the drug formulation.

Improving patient comfort 

Through minimising cellular irritation and allergenic reaction potential.

Super Refined Parenteral

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Adjuvants

For more than 80 years Croda has been dedicated to safe and effective adjuvants suitable for use in both human and veterinary vaccines.

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Pharmaceutical solubility guide

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.

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Super Refined™ Polysorbate 80

Super Refined Polysorbates solubilise and stabilise the most sensitive active ingredients across dosage forms including injectable and oral Super Refining removes impurities (including primary and.....

Super Refined™ Castor Oil

Super Refined™ Castor Oil

Super Refined Castor Oil is a highly purified version of naturally derived castor oil which has a high degree of functionality making it an extremely useful excipient However this increased.....

Scientist creating health care formulation at Croda

Super Refined™ Propylene Glycol

Super Refined Propylene Glycol is a highly purified propylene glycol that has a wide use in pharmaceutical formulations as a solvent stablilising agent water-miscible cosolvent plasticiser.....

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Topical

Our extensive experience in skin science has led to the development of innovative ingredients that enhance the efficacy and patient perception of topical pharmaceuticals. Our topical excipients include drug delivery systems, skin penetration enhancers, solubilisers, emulsifiers and emollients.

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Oral

The development of oral drugs presents several challenges, including low solubility, instability of the formulation and ineffective delivery of the IFA. The selection of the correct oral excipient during the initial stage of development is a critical step in achieving the success of the formulation.

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Auricular, ophthalmic and nasal

Developing drugs to be delivered through the ophthalmic, auricular and nasal routes requires focus on essential factors, such as drug stability and endotoxin levels, which can impact the success of the formulation.

Doctor giving a senior woman a vaccination.

Can our range of vaccine adjuvants support your injectable formulation

Adjuvants are used in vaccine production to accelerate, prolong, or enhance antigen-specific immune responses. They help to raise an early, long-lasting and efficient immune response to the vaccine. This increases vaccine efficacy and provides a high degree of protection from the disease against which you are vaccinating.

Adjuvants can help to reach the same level of immune protection with fewer injections or a lower dose than when vaccinating with the non-adjuvanted antigen alone. 
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