Development of sustained release formulation for rabies vaccine using inorganic nanolayers as delivery system

Rabies is a viral disease that causes acute encephalitis and is usually transmitted to humans by a bite from an infected animal. It is also said to be the mother of all infectious diseases. It is fatal if post-exposure prophylaxis is not administered before the onset of severe symptoms. Rabies accou

Project Title

Development of sustained release formulation for rabies vaccine using inorganic nanolayers as delivery system

Project Area of Specialization

Biomedical Engineering

Project Summary

Rabies is a viral disease that causes acute encephalitis and is usually transmitted to humans by a bite from an infected animal. It is also said to be the mother of all infectious diseases. It is fatal if post-exposure prophylaxis is not administered before the onset of severe symptoms. Rabies accounts for an estimated 100,000 human deaths each year, mostly in the developing countries. It is estimated that above 30,000 people die each year in rabies in Asia and nearly 5,000 deaths been reported annually due to rabies, in Pakistan. Rabies related deaths are increasing in Pakistan due to acute shortage of life-saving anti-rabies vaccine (ARV). Another main problem which greatly reduces the effect of imported (ARV) is changing of temperature. In adition, hot weather of Pakistan results in an ineffective post-exposure treatment. The requirement of maintaining cold-sotrage for the ARV drugs makes them inaccessible at less deveoped far flung rural areas, where it is needed the most. In addition, the requirement of cold-storage also makes it colstly as well. Unfortunately, no labs in Pakistan produce ARV. Hence, it is imperative to develop anti-rabies treatment in Pakistan, with lesser dependence on the maintenance of cold-chain.

Recently, inorganic nanolayers based formulations have been widely applied in drug delivery system to treat many serious diseases because of their significant health promoting properties. We hypothesize that nano-formulation of ARV can offer thermal stability to ARV. This research project is aimed at design and develop a Nano-formulation for rabies vaccine (NFRV) from inorganic nano-layers. In this research, NFRV is prepared by intercalating (ARV) into magnesium and aluminum (Mg/Al) layered double hydroxides (LDHs). This novel (NFRV) will be highly effective and stable at normal atmospheric temperature and will be released in a sustained manner from the nano­-delivery system compared to free (ARV), thereby eliminating the need for maintaining the cold-chain.

Project Objectives

The following are the objectives to be achieved:

• To develop pre-exposure and post-exposure rabies treatment in a laboratory at Biomedical Engineering Department of Mehran UET, Jamshoro.
• Designing of efficacious, cost-effective and easily accessible nano-formulation rabies vaccine with improved thermal stability at normal atmospheric temperature
• To develop (Mg/Al) layered double hydroxide inorganic Nano-layers carrying anti-rabies vaccine with high efficacy, stability and sustained release properties.
• Development of the biocompatible anti-rabies nano drug delivery system with the ability to minimize the side effects of the ARV.
• And most importantly to design the nano drug delivery system which can deliver the vaccine at target site that would increase the therapeutic efficacy.

Project Implementation Method

The implementation method comprises of three methods

1. Synthesis of Nano-formulation for rabies vaccine

• In organic Nanolayers of Mg/Al layered double hydroxide (LDHs) are prepared by ion exchange and co-precipitation method.

anti-rabies vaccine is intercalated into Mg/Al layered double hydroxide.

2. Synthesized Nano-formulation for rabies vaccine will be characterized by following characterizing techniques to confirm whether it is successfully intercalated.

• Uv-visible spectrophotometer
• FTIR
• XRD (X-Ray diffraction)
• FESEM (field emission scanning electron microscopy)
• TEM (transmission electron microscopy)
• DLS (dynamic light scattering) 
• In vitro and in vivo tests

• Further investigations on detailed cellular mechanism of Nano-formulation for rabies vaccine will be conducted by different in vitro and in vivo tests (Cytotoxicity tests, cell viability assays, cell susceptibility tests, vaccine release study, biocompatibility tests on normal cell lines).

Benefits of the Project

• Rabies disease can be cured with a minimum side-effects as compared to the normal vaccine.
• ARV will be manufactured in Pakistan.
• ARV will be more accessible and more easily accessible in all the areas of Pakistan.
• It will save foreign exchange.
• Normal vaccine needs low temperature for restoration whereas  according to  the new research nano-formulation for rabies vaccine can be kept at normal conditions.
• It is biocompatible in a sense that it does not react with any organ and cure the disease properly.
• It is biodegradable in a sense that it releases after doing its work completely from the body.
• It has minimum side-effects as compared to normal vaccine.
• As compared to the rabies vaccine this nanolayered vaccine has greater stability and no storage problem.
• It will also benefits to the pharmaceutical companies as a drug for the welfare of mankind.
• Nano-formulation for rabies vaccine will release in a sustained manner would result in the bio-availability of the (NFRV) in the body for a longer period of time and this would reduce the dosing frequency in drug administration.
• Their  properties like sustained release of (NFRV) of the target site,which is degradation,reduction in dosing frequency, and prolong bioavailability of (NFRV) in the body would result in the shortening of the treatment duration. .

Technical Details of Final Deliverable

Vaccination is one of the most effective approaches in the prevention and control of disease worldwide.

Nano-formulation for rabies vaccine  is  an anti rabies vaccine which is highly stable at atmospheric temperature and it is also biocompatible and biodegradable .Rabies mortality rate is increasing in Pakistan so this (NFFRV)  can be easily cured the rabies disease completely.

Usually, vaccines are administered by injection. This has the problem of relatively weak immune responses due to insufficient stimulation of mucous membranes. Compared with the traditional vaccination route, oral vaccination reduces the pain of vaccination and lowers the risk of wound infection/inflammation.therefore our product is also oral vaccine, based on a rationally designed oral vaccination system, the cost is considerably reduced because robust and integral immune responses can be elicited. the normal vaccine is not very effective which causes nausia, fever when disease is cured. our vaccine causes no any side effects afterwards. As consider the rabies vaccine the Nano-formulation for rabies  vaccine is more effective and useful.

Final Deliverable of the Project

Hardware System

Core Industry

Health

Other Industries

Medical

Core Technology

Others

Other Technologies

Others

Sustainable Development Goals

Good Health and Well-Being for People

Required Resources

If you need this project, please contact me on contact@adikhanofficial.com