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High purity excipients for oral drug delivery

Oral drug development of both new and existing chemical entities often face numerous challenges including poor solubility, formulation instability and ineffective drug delivery. Regardless of the challenge, the ultimate goal is to create successful drug products with shortened development timelines. The selection of the right oral excipient during early phase development is critical to achieve this goal.

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Super Refined™ excipients for oral drug delivery

Our proprietary Super Refining process yields highly purified excipients that can maximise drug product value and are indicated to stabilise, solubilise and optimise the active ingredients in the formulation.

Oral drug value:

  • Enhanced drug performance and stability
  • Improved shelf life
  • Increased patient compliance
  • Improved bioavailability
  • Decreased formulation development time
  • Decreased time to market.

Benefits and features of high purity excipients for oral drug delivery: 

Improved API stability 

Stabilisation of an API is crucial to successful drug development. As API degradation can be initiated and accelerated by impurities that can be introduced by excipients in the formulation, carefully selecting the right oral excipient can be essential to formulation success.

Increased gelatine capsule stability

Over time, the impurities found in commonly used solvents and fillers in gelatine capsules can preferentially absorb moisture from the gelatine shell. The moisture absorption can cause the gelatine to crosslink which, ultimately, cause the capsule to harden. The hardening of the capsule can result in either cracking or longer disintegration times leading to unacceptable drug efficacy.

Improved taste impact

The impact of an excipient on the taste of an oral drug can significantly affect patient compliance and repeat purchase.

Reduced colour impurities

The Super Refining process yields a highly purified excipient with a reduction in both colour and overall impurity levels. The purification of oral excipients yields improved drug appearance as well as improved stability of the excipient; the API and drug formulation. 

Super Refined™ pharmaceutical excipients

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Creation of SEDDS and SMEDDS

Self-emulsifying drug delivery systems (SEDDS) and self-microemulsifying drug delivery systems (SMEDDS) are lipid-based formulations that aim to deliver hydrophobic drugs that typically are associated with poor water solubility and low bioavilability.

Formulation benefits for ophthalmic drug delivery - reduced peroxide levels

Low moisture

Formulation benefits for ophthalmic drug delivery - reduced cellular irritation

Low peroxide levels

Formulation benefits for ophthalmic drug delivery - Reduced endotoxin levels

Multicompendial

USP/NF, Ph.Eur., JPE and ChP
View SEDDS and SMEDDS

Oral excipient offering:

Recommended high purity components for SEDDS and SMEDDS development:

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...
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Super Refined Cottonseed

Super Refined™ Cottonseed

Cottonseed-derived triglyceride that has been Super Refined™ to remove impurities.
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Scientist creating health care formulation at Croda

Super Refined™ GTCC

Super Refined GTCC is a high purity mixed ester consisting primarily of the saturated fatty acids caprylic (C8) and capric (C10) acid. Products of this type are commonly referred to as medium chain...
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Super Refined Oleic Acid

Super Refined™ Oleic Acid

Highly purified oleic acid is used as a co-emulsifier in topical pharmaceutical formulations. Ideal for nasal drug delivery and as a penetration enhancer in transdermal formulations. In addition, it...
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Super Refined Peanut Oil

Super Refined™ Peanut Oil

Peanut-derived triglyceride, that has been Super Refined™ to remove impurities. Purified to yield a water-white, odourless, neutral non-polar lipid with a low peroxide value. Used as an excipient in...
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Super Refined Sesame Oil

Super Refined™ Sesame Oil

Sesame-derived triglyceride that has been Super Refined™ to remove impurities. Purified to yield a water-white, odourless, neutral non-polar lipid with a low peroxide value. Its major use is as a...
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Super Refined Corn Oil

Super Refined™ Corn Oil

Corn-derived triglyceride that has been Super Refined™ to remove impurities. Purified to yield a water-white, odourless, neutral non-polar lipid with a low peroxide value. Ideal for use in...
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Super Refined GMCC

Super Refined™ GMCC

Super Refined™ GMCC is a high purity mixture of monoglycerides and diglycerides of caprylic and capric acids. It is used to produce stable emulsions and to modify viscosity. It functions as a...
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Super Refined Olive Oil

Super Refined™ Olive Oil

Olive-derived triglyceride that has been Super Refined™ to remove impurities. Purified to yield a water-white, odourless, neutral non-polar lipid with a low peroxide value. Can be used topically as an...
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Super Refined Soybean Oil

Super Refined™ Soybean Oil

Soy-derived triglyceride that has been Super Refined™ to remove impurities. Purified to yield a water-white, odourless, neutral non-polar lipid with a low peroxide value. Used in pharmaceutical...
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Explore our product offering

We offer high purity, multi-compendial, pharmaceutical excipients for small molecule drug delivery. Our portfolio of high purity excipient products and speciality chemistries solve formulation challenges and enhance drug delivery across a variety of administration routes and dosage forms.

Super Refined™ excipients

Super Refined excipients are stripped of a number of oxidative impurities, such as peroxides, aldehydes, and catalyst residues. The removal of these problematic species helps to reduce negative API & excipient interactions, maintaining both the stability of the drug and the final formulation. In addition, the removal of these impurities can minimise cellular irritation, reduce taste impact, and potentially decrease allergenicity. 

We have a large variety of products, ranging from various polysorbates, polyethylene glycols (PEG), esters, vegetable oils, and more. 
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