Comparative study of physical and enteric properties of intrinsically acid-resistant soft-gel versus an enteric coated soft-gel of peppermint oil - BC-639

Project type: Research
Desired discipline(s): Animal science, Life Sciences, Food science, Medicine
Company: GelEntroCeutics Inc.
Project Length: 6 months to 1 year
Preferred start date: As soon as possible.
Language requirement: English
Location(s): Canada; Canada; Canada; Canada
No. of positions: 1
Desired education level: Master's
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About the company: 

Our company has come up with a new formulation to make intrinsically acid-resistant enteric soft-gelatin capsules.

Enteric capsules are those that bypass the stomach and disintegrate into the intestine.

Capsules need to be enteric in many cases as many medications may irritate the stomach or due to the higher efficacy and results stability of the drug, should they disintegrate in the intestine.

Previously, capsules were made acid-resistant by coating them with another layer of acid-resistant excipients. This means massive capital investment in infrastructures, a higher rate of waste and failure, labour, and use of raw material.

Our formulation will enable pharmaceutical and nutraceutical companies to make intrinsically acid-resistant enteric soft-gelatin capsules without the need to go through the coating process. With a few changes (addition of excipients) in the raw material mixture of the soft-gelatin capsules, our formulation will produce Enteric Soft-Gelatin Capsules.

Describe the project.: 

Gastro-resistant (enteric) formulations allow to:

  • Minimize adverse effects of drug substances such as nausea, irritation of gastric mucosa and its associated consequences, belching and undesirable taste of some medications.
  • Deliver drug intended for local action in intestines.
  • Protect the drug substances from degradation in the acid environment of stomach.

However, formulating soft gelatin capsules in the form of enteric has always been challenging. The conventional method of enteric coating suffers from some serious disadvantages such as flaking and deformation of softgels during the coating process. Furthermore, coating process needs its own machine and related facilities which makes the process more time-consuming and costy.

Our team has developed an intrinsically acid-resistant gelatin mass which could be directly used in encapsulation process without the need to go through the coating process. The shells of soft gelatin capsules which are made by our method will be insoluble in acidic condition of stomach and thus will not release their content in stomach but they will disintegrated at the 6.5 pH of intestine.

The present study is aimed at:

  • Comparing the microscopic images of enteric coated softgels and intrinsically acid-resistant softgels                                                                          
  • Comparing the disintegration profile of enteric coated softgels and intrinsically acid-resistant softgels
  • Comparing the dissolution (release) profile of enteric coated softgels and intrinsically acid-resistant softgels
  • Comparing the moisture content of the two softgels
  • Comparing the physical and mechanical properties of the two softgels

Methodology/techniques that will be used:

  • Disintegration test according to USP method for enteric softgels
  • Dissolution test according to USP method for enteric softgels
  • Moisture measurement
  • SEM (Scanning Electron Microscopy)
  • AFM (Atomic Force Microscopy)
  • Texture analysis to evaluate wall hardness and elasticity of softgels

Required expertise/skills: 

  • Being familiar with pharmacopeia methods of dissolution, disintegration and physical properties tests of softgel capsules according to the USP methods
  • Being able to arrange for microscopic imaging of the softgels (SEM and/or AFM)
  • Being familiar and able to conduct moisture analysis of the softgels
  • Being able to conduct the tests to measure load strength of the capsules