Assembling nasal device

CriticalSorb Absorption Promoter

CriticalSorb is a proprietary absorption promoter that has the potential to provide a viable alternative to injection for a wide variety of biological and challenging small molecule drugs.

Critical Pharmaceuticals has used the technology to develop CP024, a nasal growth hormone product in Phase 1 development that has established clinical proof of concept for CP024 and the CriticalSorb technology. In the Phase 1 clinical trial, CP024 was shown to be well tolerated and able to induce insulin‐like growth factor 1 (IGF‐1) to the same levels as a subcutaneous injection of the marketed product. IGF‐1 is the main mediator of hGH activity in the body and a clinically relevant indicator of bioactivity.

In addition, Critical Pharmaceuticals has used the CriticalSorb technology in preclinical studies with risperidone (a small molecule anti‐psychotic), insulin (a small protein for the treatment of diabetes) and two partner programs with novel peptide drugs. The bioavailability of intranasal insulin using CriticalSorb is approximately 100% relative to subcutaneous injection compared to <1% without CriticalSorb. Furthermore, the absorbed insulin exerts a pharmacodynamic effect lowering blood glucose by a similar amount to that of the subcutaneous injection.

CriticalSorb is a pharmaceutically acceptable excipient approved by the FDA as generally regarded as safe (GRAS). It has a drug master file (DMF), and is used in currently marketed products as a solubility enhancer for intravenous and oral administration. In preclinical toxicology studies, CriticalSorb has been found to be nontoxic and not irritating to the skin or eyes and was well tolerated by the nasal mucosa in acute, 14 day and 6 month repeated dose chronic toxicity studies. Furthermore it is not mutagenic to bacteria, mammalian cells and mammals, and no developmental toxicity or teratogenicity has been found. Using conventional manufacturing technologies and delivery devices, possible formulation presentations include liquid nasal sprays or powders for nasal administration.

Key properties of CriticalSorb™ are:

  • A pharmaceutically acceptable excipient (GRAS) used in marketed products for intravenous and oral administration
  • A Drug Master File is available.
  • Preclinical tox studies have shown CriticalSorb™ to be non-toxic, with no irritation to the skin or eyes or nasal mucosa.
  • Available as liquid or powder formulations.
  • Promotes absorption of peptides and proteins such as teriparatide (~4kDa), insulin (~6kDa) and human growth hormone (22kDa) across the nasal mucosa in preclinical studies with exceptionally high bioavailabilities.
  • Generally applicable to all drugs e.g. small molecules, proteins, peptides, DNA.
  • Protected by pending patents worldwide.
CP024 Nasal hGH

measuring height

CP024 has completed two Phase 1 clinical trials where our intranasal growth hormone has shown comparable activity to injection.

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CriticalMix Technology

CriticalMix rig

CriticalMix enables the manufacture of highly active sustained release depot products for bimonthly, monthly or less frequent injection.

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Richard Seabrook, Wellcome Trust
“Technologies for non-injectable administration of complex drugs like human growth hormone are desperately needed. We are very pleased to be funding this application of CriticalSorb™ which may avoid patient discomfort and improve eventual outcomes for this patient population. We look forward to Critical’s results.”