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APS (Alginate - Pectin - Starch technology) - Drug and Nutrient Encapsulation 

 

This technology was developed to create a versatile starch based encapsulation system that could deliver nutrients and drugs to different parts of the gastro-intestinal (GI) tract and mask taste. International patent granted.  Its particular properties are:

  • Physically encapsulates drugs/nutrients in a polysaccharide matrix
  • Uses well established safe (GRAS) materials only - starch, pectin and alginate polysaccharides plus calcium salt gelling agents
  • Is manufactured using well established technologies found in most pharmaceutical companies (and toll manufacturers) - namely spray dryers, wet granulators, etc.
  • Can be used in powder, tablet, capsule or liquid formats
  • Combinations of drugs and nutrients (e.g. amino acids) can be used
  • Low cost of manufacture in view of the freely available materials and processing requirements
  • Can be formulated to provide effective taste masking
  • Can be formulated to provide slow/controlled release due to enzyme hydrolysis in the GI tract
  • Biodegradable
  • Very versatile drug delivery system

Relevant References

  • Rassis, D. K., Saguy, I. S. and Nussinovitch, A. (1998) Physical properties of alginate-starch cellular sponges. Journal of Agricultural and Food Chemistry 46 (8), 2981-2987.
  • Abdulmola, N. A., Richardson, R. K. and Morris, E. R. (2000) Effect of oxidised starch on calcium pectinate gels. Food Hydrocolloids 14 (6), 569-577.
  • Rassis, D. K., Saguy, I. S. and Nussinovitch, A. (2000) Physical and chemical characteristics of alginate-starch sponges. Hydrocolloids, 203-210.
  • Chan, L. W., Lim, L. T. and Heng, P . W. (2000) Microencapsulation of oils using sodium alginate. Journal of Microencapsulation 17 (6), 757-766.
  • Dembcznski, R. and Jankowski, T. (2000) Growth of lactic acid bacteria in alginate/starch capsules. Progress in Biotechnology 17, 291-294.
  • Sultana, K., Godward, G., Reynolds, N., Arumugaswamy, R., Peiris, P. and Kailasapathy, K. (2000) Encapsulation of probiotic bacteria with alginate-starch and evaluation of survival in simulated gastrointestinal conditions and in yoghurt. International Journal of Food Microbiology 62 (1-2), 47-55.
  • Tal, Y., van Rijn, J. and Nussinovitch, A. (2000) Starch as a filler, matrix enhancer and a carbon source in freeze-dried denitrifying alginate beads. Hydrocolloids, 347-354.
  • Dembcznski, R. and Jankowski, T. (2002) Growth characteristics and acidifying activity of Lactobacillus rhamnosus in alginate/starch liquid core capsules. Enzyme and Microbial Technology 31 (1-2), 111-115.
  • Dimantov, A., Kesselman, E. and Shimoni, E., (2004) Surface characterisation and dissolution properties of high amylose corn starch-pectin coatings. Food Hydrocolloids 18 (1), 29-37.
  • Juliano, C., Gavini, E., Cossu, M., Bonferoni, M. C. and Giunchedi, P. (2004) Mucoadhesive alginate matrices containing sodium carboxymethyl starch for buccal drug delivery: in vitro and in vivo studies. STP Pharma Sciences 14 (2), 159-163.
  • Desai, K. G. H. (2005) Preparation and Characteristics of High-Amylose Corn Starch (HACS)/Pectin Blend Microparticles: A Technical Note. AAPS PharmSciTech. 6 (2), E202-E208.
  • Iyer, C. and Kailasapathy, K. (2005) Effect of co-encapsulation of probiotics with prebiotics on increasing the viability of encapsulated bacteria under In vitro acidic and bile salt conditions and in yogurt. Journal of Food Science 70 (1) , M18–M23.
  • Kim, Y. J., Park, H. G., Yang, Y. L., Yoon, Y., Kim, S. and Oh, E. (2005) Multifunctional drug delivery system using starch-alginate beads for controlled release. Biological and Pharmaceutical Bulletin 28 (2), 394-397
  • Puttipipatkhachorn, S., Pongjanyakul, T. and Priprem, A. (2005) Molecular interaction in alginate beads reinforced with sodium starch glycolate or magnesium aluminium silicate and their physical characteristics. International Journal of Pharmaceutics 293 (1-2), 51-62.
  • Donthidi, A. R., Al-Ghazzewi, F., Aidoo, K. And Tester, R. F. (2006) Effect of lecithin on viability and stability of probiotics. Journal of Pharmacy and Pharmacology, BPC Abstracts, Supplement 1, 33-35.
  • Kailasapathy, K. (2006) Survival of free and encapsulated probiotic bacteria and their effect on the sensory properties of yoghurt. LWT-Food Science and Technology 39 (10), 1221-1227.
  • Kailasapathy, K., Perera, C. and Phillips, M. (2006) Evaluation of alginate-starch polymers for preparation of enzyme microcapsules. International Journal of Food Engineering 2 (2), Article 8.
  • Madziva, H., Kailasapathy, K. and Phillips, M. (2006) Evaluation of alginate-pectin capsules in Cheddar cheese as a food carrier for the delivery of folic acid. LWT-Food Science and Technology 39 (2), 146-151.
  • Ding, W. K. and Shah, N. P. (2007) Acid, bile and heat tolerance of free and microencapsulated probiotic bacteria. Journal of Food Science 72 (9), M446-M450.
  • Haider, T. and Husain, Q. (2008) Concanavalin A layered calcium alginate-starch beads immobilised beta-galactosidase as a therapeutic agent for lactose intolerant patients. International Journal of Pharmaceutics - in press.
  • Singh, B., Sharma, D. K. and Gupta, A. (2008) A study towards release dynamics of thiram fungicide from starch-alginate beads to control environmental and health hazards. Journal of Hazardous Materials - in press.

Patents

Patent application in PCT route (WO9953902), so far granted as: EP1079810; US6649191; AU760263B

Beta-limit dextrin (BLD) - Oral Delivery (Flash Melt) System

 

As a scientific curiosity, BLD has a well established place within the scientific literature, being derived from hydrolysis of starch (amylopectin) by treatment with ß-amylase. In commercial terms the material has unique properties and provides an excellent:

  • Inhalation carrier (which can be cleared very quickly from the mucosal membranes by endogenous amylases)
  • Buccal melt wafer (which can be used in place of gelatine to deliver, for example, migraine therapies, cough and cold therapies, hay fever therapies, nicotine and breath fresheners etc. to the mouth and hence body) with excellent stability and associated mouth feel
  • Functional element in films
  • Excipient for tableting systems (giving options beyond gelatinised starch)
  • Good base for liquid dosage systems in view of its high solubility and stability
  • Tasteless
  • Low osmotic pressure calorie provider in drinks/foods where the molecule is very soluble and stable - useful for providing calories for the malnourished and elderly
  • Useful for dysphagia products
  • Safe enzymic derivative of starch
  • Converted to glucose rapidly in the small intestine
  • Very unreactive during processing due to absence of free reducing groups
  • Effective gelatine replacement matrix in different formats

The main focus of the technology is flash oral release of drugs and nutrients where different rates of disintegration can be achieved from ~5 seconds to a few minutes.

Relevant References

  • Tester, R. F. (2005) ß-Limit dextrin - a new food and pharmaceutical resource, pp 448, in: Abstract of the 56th Starch convention in Detmold. Starch/Stärke 57, 442-451.

Patents

Patent Application in PCT route (WO2004014156), so far granted as: NZ537552

Slow Energy Release Starch (SERS) - For Long Duration of Glucose Release in the Body and for Hypoglycaemia (Hypoglycemia) Management 

 

The SERS was developed due to a request by a metabolic disorder centre in the UK where a product providing up to ten hours release of energy (as glucose) was required to manage hypoglycaemia. The technology has completed clinical trials successfully in Europe and the USA for: Consumer Nutrition Products, Glycogen Storage Disease (GSD) and Type 1 Diabetes.

Fundamentally, it is designed to treat hypoglycaemia over a long period of time (including nocturnal). It:

  • Is a physically modified starch
  • Uniquely provides up to ten hours release of energy as glucose in man and has associated advantages over products ('corn starch') currently used to treat hypoglycaemia in different metabolic disorders (e.g. GSD), liver dysfunction, diabetes etc.
  • Clinical trials indicate blood glucose, lactate and insulin are influenced positively by consumption of this new material
  • Can be used in combination with other diabetic therapies
  • Derived from starch as a physical (non-chemical or biological modification) and hence GRAS
  • Low manufacturing cost using relatively straightforward equipment
  • Very stable post manufacturer and straightforward to process, flavour etc. if required
  • No inherent taste
  • Energy source for sports, extreme activities, armies etc.

Relevant References

  • Kaufman, F. R., Halvorson, M. and Kaufman, N. D. (1995) A randomised, blinded trial of uncooked cornstarch to diminish nocturnal hypoglycaemia at Diabetes Camp. Diabetes Research and Clinical Practice 30, 205-209.
  • Sajilata, M. G., Singal, R. S. and Kulkarni, P. R. (2006) Resistant starch - A review. Comprehensive Reviews in Food Science and Food Safety 5, 1-17.
  • Raben, A., Tagliabue, A., Christensen, N. J., Madsen, J., Holst, J. J. and Astrup, A. (1994) Resistant starch: The effect on postprandial glycaemia, hormonal response and satiety. American Journal of Clinical Nutrition 60, 544-551.
  • Rafkin-Mervis, L. E. and Marks, J. B. (2001) The science of diabetic snack bars: A review. Clinical Diabetes 19, 4-12.
  • Yamada, Y., Hosoya, S., Nishimura, S., Tanaka, T., Kajimoto, Y., Nishimura, A. and Kajimoto, O. (2005) Effect of bread containing resistant starch on postprandial blood glucose levels in humans. Bioscience, Biotechnology and Biochemistry 69 (3), 559-566.
  • Bhattacharya, K., Orton, R. C., Qi, X., Mundy, H., Morley, D. W., Champion, M. P., Eaton, S., Tester, R. F. and Lee, P. J. (2007) A novel starch for the treatment of glycogen storage disease. Journal of Inherited Metabolic Disorders 30, 350-357.

Patents

Patent application in PCT route (WO2005044284), so far granted as: 

Prebiotic product - to Promote the Growth of Body (Vagina and Skin) and Gut Friendly Bacteria 

 

Prebiotics represent the sources of energy that gut (and body) friendly bacteria use for growth.

This product is derived from a food grade polysaccharides (glucomannans, especially konjac glucomannans) where the structure and composition make it uniquely valuable as a prebiotic component of the diet and to promote 'body friendly' bacteria growth (skin and vagina especially) at the expense of pathogens. The material can both in vitro and in vivo stimulate the probiotic bacteria growth. The probiotic bacteria utilise very effectively this mannose rich material.

Recently completed animal trials indicate that the material:

  • increases the proportion of lactic acid bacteria in the gut
  • but decreases the number of pathogens

Also:

  • In comparison with inulin and inulin derivatives it generates ~100 times more Lactobacilli biomass as a prebiotic material
  • Very effective material for supporting the growth of 'difficult' gut friendly bacteria like Lactobacilli and Bifido species
  • May be used in a variety of clinical applications including thrush therapy in the vagina and skin creams to treat infections
  • GRAS process for manufacture where syrups and dried material can be supplied which can then be formulated into finished products
  • Sugar profile of the material has a specific benefit to support probiotic bacteria growth and has other advantages over competitive materials
  • Process stable
  • Very cost effective compared to inulin and related materials
  • Has been used successfully in dairy (e.g. yoghurt ) type production but its high solubility makes it universally valuable in many product formulations
  • Industrial applications beyond prebiotic use, including industrial growth media etc.
  • No taste
  • Soluble fibre source
  • Manufacturing route established with international manufacturing partner

Relevant References

  • Lu, X-J., Chen, X-M., Fu, D-X., Cong, W. and Ouyang, F. (2002) Effect of Amorphophallus konjac oligosaccharides on STZ-induced diabetes model of isolated islets. Life Sciences 72, 711-719.
  • Kitamoto, N., Kato, Y., Ohnaka, T., Yokota, M., Tanaka, T. and Tsuji, K. (2003) Bactericidal effects of konjac fluid on several food-poisoning bacteria. Journal of Food Protection 66 (10), 1822-1831.
  • Chen, H-L., Fan, Y-H., Chen, M-E. and Chan, Y. (2005) Unhydrolysed and hydrolysed konjac glucomannans modulated caecal and faecal microflora in Balb/c mice. Nutrition 21, 1059-1064.
  • Chen, H-L., Cheng, H-C., Liu, Y-J., Liu, S-Y., and Wu, W-T. (2006) Konjac acts as a natural laxative by increasing stool bulk and improving colonic ecology in healthy adults. Nutrition 22, 1112-1119.
  • Kumao, T., Fujii, S., Asakawa, A., Takehara, I. and Fukuhara, I. (2006) Effect of coffee drink containing mannooligosaccharides on total amount of excreted fat in healthy adults. Journal of Health Science 52 (4), 482-485.
  • A-Ghazzewi, F. H., Khanna, S., Tester, R. F. and Piggott, J. (2007) The potential use of hydrolysed konjac glucomannan as a prebiotic. Journal of the Science of Food and Agriculture 87, 1758-1766.
  • Elamir, A. A., Tester, R. F., Al-Ghazzewi, F. H., Kaal, H. Y., Ghalbon, A. A., Elmegrahai, N. A. and Piggott, J. R. (2008) Effects of konjac glucomannan hydrolysates on the gut microflora of mice. Nutrition and Food Science 38, 422-429.

Patents

Patent application in PCT route (WO2005111195), so far granted as:

Gastric Retentive System (GRS) 

 

This technology has been built around gastric rafts where 'traditional' alginate type rafts are interspersed with starch type polymers creating rafts which are, compared to pure alginate, more durable, have controlled drug and nutrient delivery functionality (due to starch interactions), can control the flow of nutrients and drugs through the stomach, avoid large fibre dosages and are lower cost than pure alginate matrices. Trials for different applications (see below) are progressing with a number of food, clinical nutrition and pharmaceutical companies.

Satiety

The matrices:

  • Provide satiety using physical extension of the stomach with small quantities of food grade polymers - starch, alginates and pectin
  • Provide a mechanism whereby starch and hence ultimately glucose release from the stomach to the small intestine is controlled - with associated satiety and dietary management
  • Avoid the consumer taking large quantities of dietary fibre with associated unpleasant gut transit issues
  • Provide a mechanism whereby snacking between meals is avoided
  • Reduce meal size
  • Provide a product which is easy to carry and use
  • By appropriate formulation, give a pleasant sensory experience for consumers
  • Avoidance of any drugs
  • Provide an option to treat satiety without the need for surgical intervention
Gastric Delivery

The technology can be used to retain nutrients and drugs in the stomach. This can control transit through the intestine and hence absorption, plus provide local therapeutic efficacy.

GORD (GERD)

Gastro-Oesophageal Reflux Disease can be treated with this therapy with its unique advantages over alginate rafts.

Patents

Patent application in PCT route (WO03051329), so far granted as:

Wound Management 

 

Glycologic Limited has developed specific wound management technologies - including in partnership with an international dressing manufacturer. The technological push is focused towards: developing novel dressing structures; controlling the way that dressing interact with wounds during healing; controlling the way that drugs are delivered to wounds.

Diagnostic Kits 

 

The Company has developed a number of diagnostic kits to quantify components of foods.

Some of the materials assayed for, are natural where the detection provides quantification and nutritional advantage.

Other kits are directed towards clinical medical conditions where assaying dietary/blood concentrations of specific nutrients is essential for disease maintenance.

The last group of kits are directed towards toxic components in foods and drinks.

A major press release with an established partner regarding a specific kit will be made soon.

Technologies Currently Under Development

  • Treatment for vaginal thrush (prebiotic)
  • Solubilisation technology for drugs
  • Colonic delivery system
  • Large drug dosage delivery system (antibiotic, AID drugs etc.)