NiedlFree Technology

Bio-Availability Of Different Molecules

Diabetes & Oral Insulin

NiedlFree & Teriparatide

Patents

Introduction

Bio-Pharmaceuticals, also known as a biologics or biologicals, differ from other pharmaceutical products, or small molecules, in that they are created using biological processes rather than being chemically synthesized. They are generally large, complex biomolecules containing a peptide-bond linked amino acid sequence (containing from about fifty up to thousands of amino acid residues). They include a wide variety of medicinal products such as vaccines, blood or blood components, somatic cells, gene therapy, tissue, recombinant therapeutic proteins, or living cells that are used as therapeutics to treat diseases. Because of their complex nature combined with the size of those molecules, it creates a challenge in delivering those other than the injectable route.

NiedlFree technologies is a disruptive technology platform transforming injectable biologics into delivery by either nasal or oral routes. Significant aspects of NiedlFree’s technology are high Bio-availability combined with three ‘C’ s – Comfort, Convenience & Compliance. Its versatility extends to include a variety of drugs with a wide range of medical applications.

Products Under Development at NiedlFree

NiedlFree's Technology

Successful evolution of our technology is the result of more than two decades of dedicated R&D work.

Nanoparticles are designed to meet specific requirements of the chosen molecule, its size, solubility i.e., hydrophilic or hydrophobic, iso-electric pH, presence of receptors  etc.

Size and functionalization of the nanoparticles is carried out based on the physico-chemical characteristics of the drug to enhance its absorption from epithelial surface into systemic circulation resulting higher bio-availability.

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Bio-Availability Of Different Molecules

Various in-vivo studies on different molecules delivered on NiedlFree’s Platform provide volume of evidence on high bio-availability unmatched by any other company so far.

Diabetes & Oral Insulin

The rising prevalence of diabetes especially after the Covid pandemic is a growing problem in the developed countries. Diabetes is the world’s fastest growing chronic disease. It currently affects 246 million people worldwide and this number is expected to rise to 380 million by 2025.

INDIAN SCENARIO

Over 30 million people have now been diagnosed with diabetes mellitus in India. The estimate of the actual number of diabetics in India is around 40 million. This means that India has the highest number of diabetics, more than any other country in the entire world.

 In India, the type of diabetes differs considerably from that in the Western world. Type 1 is considerably rare, and only about 1/3 of type II diabetics are overweight or obese. Diabetes is also beginning to appear much earlier in life in India, meaning that chronic long-term complications are becoming more common. The implications for the Indian healthcare system are enormous.

Diabetes is associated with a range of severe co-morbidities, the most significant of which include cardiovascular disease, hypertension, and kidney disease. Treatment of type 1 diabetes and in several type 2 cases generally involves thrice daily monitoring of blood glucose levels and injection of insulin for the rest of the diabetic patient’s life. Personal observations suggest that many patients do not observe this regime, and do not monitor their blood glucose 3 times per day due to the pain associated with blood sampling

This route of administration by injection has led to several treatment-associated sequelae. High local concentrations of insulin result in lipodystrophy, possibly due to areas of local down-regulation of insulin receptors in adjacent adipocytes.

Many patients are needle-phobic, and there is a high rate of non-compliance (around 30%) in diabetic patients, which leads to improper treatment resulting in undesirable sequelae that could have been prevented with correct treatment.

Many of the problems associated with administration of insulin result from the reliance on sub-cutaneous injection as a route of delivery for insulin, as insulin currently cannot be given orally. The main barriers to oral delivery of insulin (or most other proteins) are firstly, the harsh proteolytic environment in the intestine, which leads to rapid degradation of proteins such as insulin when administered via this route, and secondly due to the requirement/need to have a transport mechanism to get the insulin to bind to and be taken up by the intestinal epithelial cells, with subsequent transport across these cells and release into the hepatic portal circulation.

NIEDLFREE and ORAL INSULIN

The technology behind NiedlFree’s Oral Insulin combines the use of four different mechanisms:

  • protects insulin from proteolytic degradation in the harsh environment of the intestine and maintains it in a monomeric form to present it in a biologically active form to its receptors;
  • exploits a unique transport system in the small intestine;
  • insulin taken up in NiedlFree’s formulation is independent of the previously mentioned receptor system. The different locations of the two receptors results in an extended synergistic uptake of oral insulin, which in turn reflects a prolonged hypoglycemic effect.
  • Lastly, NiedlFree’s scientists have developed a unique formulation that utilizes a proprietary targeted nano-system to increase dosage levels (i.e. loading), thereby overcomes one of the major hurdles faced in the oral delivery of targeted proteins or peptides.

NiedlFree’s Oral Insulin has consistently demonstrated a relative bio-availability more than 90%, as compared to SC route, the highest by the industry standards.

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NiedlFree & Teriparatide

Around the world, one in three women and one in five men over the age of fifty will suffer a broken bone due to osteoporosis. Throughout life, bone is constantly being renewed, with new bone replacing old bone- and this helps to keep our skeleton strong. But for people with osteoporosis, more and more bone is lost and not replaced.  This means that the bones gradually become brittle and more likely to break.  

Fractures that are most often associated with osteoporosis are at the hip, spine, and wrist. Fractures of the spine are the most common, yet many people dismiss the back pain as just a sign of getting older and don’t get proper diagnosis.

In women over 45 years of age, fractures due to osteoporosis result in more days spent in hospital than many other diseases, including diabetes, heart attack and breast cancer.

  • Up to 20-24% of patients die in the first year after a hip fracture
  • Hip fracture survivors experience loss of independence, with 40% unable to walk independently and 60% requiring assistance a year later, 80% are restricted in other activities, such as driving and grocery shopping.
  • 33% of hip fracture patients are totally dependent or in a nursing home in the year after a hip fracture
  • A fracture not only affects people physically and emotionally but reduces overall quality of life, often causing depression and isolation as people reduce social interaction or are no longer able to do the activities they used to do.
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Osteoporosis is a disease which makes bones weak and fragile. Osteoporosis literally means ‘porous bone’. It is a condition where bones become thin and lose their strength, as they become less dense and their quality is reduced. This greatly increases the risk of breaking a bone even after a minor fall or bump. The disease has no obvious symptoms hence, many people do not know they have osteoporosis until they suffer a fracture. Fractures can be life-altering, causing pain, disability, and loss of independence. That is why it is important to prevent osteoporosis!

Teriparatide, PTH (1-34) is the international non-proprietary name (INN) for the biologically active 34-amino acid N-terminal fragment of the 84-amino acid native parathyroid hormone, PTH (1-84). We at NiedlFree used synthetic Teriparatide supplied by a renowned company, the peptide sharing identical affinity for the parathyroid hormone (PTH) surface receptors as well as possessing the same biological activity.

NiedlFree’s Teriparatide formulation has been evaluated for its plasma concentration levels and bioavailability after its administration through Sub-cutaneous and Intra-nasal route routes.

The relative bio-availability has been reported to be around 72% with Tmax reaching at 30 mins following nasal administration.