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For the last decade, groups of cell biologists, chemists and physicists all over the world have been focusing their motivation of research for the improvement of human life. Biological backgrounds interpreted with the chemical understandings of a living cell have led physicists to fabricate “Intelligent Devices” sensing alternat

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ive to those organs which are naturally integrated in the human body.

Broadly speaking these built-in or integrated organs (eye, nose, skin, ear, tong, heart, lungs, etc) in the human body are the devices which provide a man “a signal” of an image, touch, taste, hearing, smell. These impulsive signals are then transmitted throu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

gh the tissue to the respective part of the central processing unit, the brain. The theme of the today’s research is to imply this simple natural process, design and fabricate a substitute to these sensors when the built-in sensor does not work for certain reasons. These substituted devices are called Implants. An example of suc

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

an implant is the Retinal Implant.

The Retinal Implant

An eye is a precious part of a human which plays an integral sensory role for the visual capability of the vision. Because of many factors this part may come to loose its visionary sensing power in some human beings. For example, Age-Related Macular Degeneration (

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ARMD) is a progressive disease of the retina wherein the light-sensing cells in the central area of vision (the macula) stop working and eventually die Ref [1]. By replacing the dead part of retina with the retinal implants, theoretically and practically, the diseases related with retina can hopefully be controlled.

The prin

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

iple and working of an Eye

The construction of the Eye is similar to that of a camera. In principle, the visible light is focused by a lens on a screen called the retina and the image is realized. Fig.1 (please find at http://webvision.med.utah.edu/sretina.html) shows a cross-section of human eye ball with its different par

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ts. The Retina, being the most significant in the functioning of the eye, is composed of layers with different cells as shown in Fig. 2 (please find at http://www.farlops.com/images/photos/retina.jpg ) The light first enters the Nerve Fiber Layer and the Ganglion Cell Layer, under which most of the nourishing and aiding blood

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

vessels of the retina are located. This is where the nerve begins, picking up the impulses of the acquired image from the retina and transmitting them to the brain. The light is received by the Photoreceptor cells called Rods and the Cones. These cells convert light into nerve impulses, which are then processed by the retina and

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

sent though nerve fibers to the brain. The nerve fibers exit the eyeball at the Blind spot and reach the brain through the Optic nerve. The further anatomical details can be found elsewhere. Ref. [2]

The Retinal Implant Functionality

To help visually impaired patients, a visual prosthesis could be designed to be placed

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

in the eye, either under or on the retinal surface, sub retinal areas, etc, in the optic nerve, or in the visual cortex of the brain. Each approach has certain advantages and disadvantages. [Ref. 3] Based on the above principal idea, the light is sensed by a large assembly of photo-receptor diodes integrated on a Chip connected

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

with the electrodes for the electrical power. This chip collects the information of the sketched image fall on it and triggers the family of cells grown on this chip. The function of this chip/implant is the same as the retinal photoreceptor cells which are connected with the bipolar cells and ganglions and transmitting the phot

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

o signal to the respective part of the optic nerve [Ref. 4]. It is not easy to explicate the phenomena for the transmission of the sensed sketch produced in the chip of photoreceptor diodes to the grown cells of the retina, and from them to the optic nerve. Biologists and chemistry people are trying to resolve these phenomenons

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

into a simple, explainable and electronically feasible for the best possible performance of the retinal implants.

Conclusion and Future work

There are certain flaws for the In-vivo application of retinal implants. Bio-compatibility, one of the first main issue, of an Implants means especially the metal electrodes and th

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

whole chip (the electronics) must be able to resist the body environment. The electrolytic properties of the blood, pH and ionic behavior of the In-vivo environment are some crucial parameters, nowadays faced by the scientists. The compatible implants should also be longtime susceptible to the animals as well as to the human be

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ings. Similarly, the diffusion of liquids through the sealing and packed retinal implant is also a great challenge that limits the working period (life) of an implant. For the commercial available synthetic materials, (plastic foils, etc) the permeability rate of water vapors is 5*10-3 g/m2/day. Scientists are seeking the best

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

possible material with the least permeation which would in turn enhance the life time stability and bio compatibility of the implant in the body. Besides the state-of-the-art device fabrication improvements, a visual prosthesis must receive two types of inputs, information about the visual signal from the retinal implant and th

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e power to run this whole electronic assembly. It is detrimental for the purposes of long-term implantation to have wires penetrating the body or imbedded batteries that could corrode and have to be replaced if not properly sealed as mentioned above. Alternatively, one can send the visual signal and power to the implant without

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the use of wires. Wireless communication can be accomplished with laser light or radiofrequency transmission. Before performing experiments on the human eye, it is necessary to perform laboratory experiments to determine safe methods of device implantation and electrical stimulation of the retina. These studies are performed i

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

vitro (i.e. outside the animal; using tissue preparations) and in vivo (i.e. in the living body). In order to carry out such experiments, approval must be obtained and granted from committees that monitor experimentation with animals and humans from all the over the world.

Ref:

1: Age Related Macular Degeneration

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

, Jennifer I Lim, ISBN 082470682X

2: An Introduction to the Biology of Vision, James T Mcllwain, ISBN 0521498902

3: Neuroprosthetics: Theory and Practice, Kenneth W. Horch, ISBN 9812380221

4: Electrical multisite stimulation of the isolated chicken retina, et. A. Stett, NMI Reutlingen, Vision Research 40 (2000) 1785-1795

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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