Introduction
The inherent experience and expertise in developing different biologics, including various biosimilars and formulating those molecules with different characteristics provides NiedlFree a broad portfolio of product profile.
A. Biosimilars
B. Oral or Nasal formulations
Following is the list of Biosimilars with hands-on experience in developing and their commercial production:
Insulin – rh-Insulin
– Insulin Aspart
– Insulin Glargine
rHGH (Recombinant human Growth Hormone
mAbs – Trastazumab
– Adalimumab
– Bevacizumab
Uniqueness of the technology
NiedlFree’s Technology Platform is unique and one of its kind in many ways. It can deliver several biologics or even some pharmaceuticals that are not highly soluble either by oral or nasal route or in some cases both by nasal and oral route.
The formulations are designed as per the individual physico- chemical characteristics of the molecule.
The formulations are further modified in order to achieve the aimed efficacy and high bio-availability delivered through the targeted site using a specific delivery device.
Oral and Nasal Formulations – A revolution in healthcare
Several factors govern oral or nasal drug absorption of biologics including solubility, mucosal permeability and stability either in the nasal mucosa or gastro-intestinal tract apart from their large size and susceptibility to degradation. We at NiedlFree, have succeeded in understanding the physico-chemical, metabolic and biological barriers etc that limit the overall drug’s pharmaco -chemical and bioavailability profile.
NiedlFree technology is a unique and versatile technology ‘platform’ that is capable of delivering a wide range of Protein or Peptide based drugs of varying sizes for varied clinical applications.
The technology incorporates selective quaternization of complex polymers combined with optimal functionalization of nano-particles resulting in high bio-availability, excellent PK profile and efficacy.
Based on physico-chemical characteristics of the given drug and targeted site of delivery, we design the formulation accordingly.
The delivery platform contains two different arms of formulation based on the specific characteristics of chosen molecule for its delivery either through Nasal or Oral route of administration.
Clinical applications include Diabetes, Oncology, Osteoporosis, Parkinson’s, Alzheimer’s and vaccines etc.
Several animal studies have successfully demonstrated effective and unparalled high bio-availability of the chosen drugs such as Insulin, Exenatide, Liraglutide, Octreotide, Adalimumab and vaccines such as Tetanus and Diphtheria toxoid etc.
The technology is secured by a series of global patents including USA, Japan, Europe (including the UK, Germany, France, Italy), Australia etc apart from nearly 40 other countries.
