New Drug Approvals

Home » Posts tagged 'Nanotechnology'

Tag Archives: Nanotechnology

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

Blog Stats

  • 4,303,324 hits

Flag and hits

Flag Counter

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,821 other subscribers
Follow New Drug Approvals on WordPress.com

Archives

Categories

Recent Posts

Flag Counter

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,821 other subscribers
DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

Personal Links

Verified Services

View Full Profile →

Archives

Categories

Flag Counter

Israeli scientists turn Nano science fiction into fact


 

Find out how Israeli scientists are manipulating the tiniest parts of matter to make life better for millions.

Think of a tiny robot transporting drugs to a cancer cell in your body. An artificial retina to restore lost sight. Self-cleaning windows and bullet-proof fabrics.

It’s all possible today with nanotechnology from Israel.

Tune into ISRAEL21c’s TLV1 radio show for a fascinating discussion of how Israeli scientists are turning science fiction into fact. Guests include Nava Swersky Sofer, founder and co-chair of NanoIsrael; Prof. Uriel Levy, head of the Nanotechnology Institute at the Hebrew University of Jerusalem; and Prof. Uri Sivan, one of the Technion’s leading nanotechnology experts……….http://www.israel21c.org/israeli-scientists-turn-science-fiction-into-fact-audio/

INNI

http://www.nanoisrael.org/

NanoIsrael 2016

About the INNI mission

President Shimon Peres holding nanotechnology priz

The INNI Board of Directors is appointed by The Chief Scientist in the Ministry of Economy.  The INNI BoD operates out of The MAGNET Program at the Office of the Chief Scientist.

The mission of INNI — the Israel National Nanotechnology Initiative is to make nanotechnology the next wave of successful industry in Israel by creating an engine for global leadership.

A primary task for INNI is to promote fruitful collaboration between Israeli and global nanotechnology stakeholders, particularly for projects that lead to continuing success in academia and industry.
To achieve this task, INNI activities include:
  • Establishing a national policy of resources for nanotechnology, with the aim of faster commercialization.
  • Long-range nanotechnology programs for scientific research and technology development in academia and industry, and promoting development of world-class infrastructure in Israel to support them.
  • Leading in the creation of projects that promote agreed national priorities; allocate their budgets and review development progress.
  • Actively seeking funding resources from public and private sources in order to implement the selected projects.
  • Promoting development of innovative local nanotechnology industries which will strongly impact Israeli economic growth and benefit investors.
  • Encouraging Academia and Industry cooperation with public access to a national database of Israel’s nanotechnology researchers and industry.  Effective access to information about Israel’s researchers and companies accelerates cooperation on R&D projects and on innovative new products. Israel’s nanotechnology National Database may be accessed here or from the link in the INNI website upper navigation menu.
Key to development of nanotechnology-based industry in Israel is promotion of academia–industry collaboration. INNI in collaboration with d&a Visual Insights has created a unique graphic mapping engine of Israel’s nanotechnology academia and industry. It is an extensive database of companies and researchers which is accessed with an integrated text and graphical mapping search engine. It is the ideal starting point to locate researchers and companies with the unique knowledge and skill sets for cooperation in research projects and the transfer of technology for innovative products and establishing new nanotechnology enterprises.

Sivan Uri .

Room 611, Lidow Building

Physics

Russell Berrie Nanotechnology InstituteTechnion - Israel Institute of Technology

Nano Area: Nano Electronics, Nano Materials & Nano Particles, Nanobiotechnology & Nanomedicine

Phone: +972-4-8293452

Fax: +972-4-8292418

Email: phsivan@tx.technion.ac.il

Personal website

Main

Ph.D.: Tel Aviv University 1988
M.Sc.: Physics, Tel Aviv University 1984
B.Sc.: Physics and Mathematics, Tel Aviv University 1982

Main Nano Field:

Selection of antibodies and peptides against electronic materials, electrical control over bioreactions, bioassembly of electronic devices.

Bertoldo Badler Chair in Physics

Former director of the Russell Berrie Nanotechnology Institute

Head of Ben and Esther Rosenbloom Center of Excellence in Nanoelectronics by Biotechnology

……………………………..
Uriel Levy
Prof. Uriel Levy named outstanding young researcher at the Hebrew University

 Prof. Uriel Levy of the Hebrew University of Jerusalem has received the Hebrew University President’s Prize as the Outstanding Young Researcher for 2010-11. The prize is awarded in memory of Prof. Yoram Ben-Porath, former president and rector of the Hebrew University.Hebrew University President Prof. Menahem Ben-Sasson said that the prize was being awarded to Prof. Levy “for his impressive list of scientific articles, for his creativity, and for his groundbreaking innovations.”

Prof. Levy is a member of the applied physics department at the Benin School of Computer Science and Engineering and is a renowned researcher in nanophotonics He is a member of the Harvey M. Kruger Family Center for Nanoscience and Nanotechnology at the Hebrew University.

A graduate of the Technion in physics and materials engineering, he subsequently earned a Ph.D. in electro-optics at Tel Aviv University in 2002. He then was awarded a Rothschild Fellowship for post-doctoral work at the University of California, San Diego, which he completed in 2006.

Prof. Levy has published until now 55 scientific articles and has had a number of his research discoveries patented.

Downloadable File: PresidentsPrize2010.doc

The NanoOpto group is affiliated with the Applied Physics Department at the Hebrew University of Jerusalem, Israel. Our research is mainly focused on Silicon Photonics, Polarization Optics, Plasmonics and Opto-Fluidics.

Our group  host SPP7 in Jerusalem from 31 of may till the 5 of June 2015:

Uriel Levy at ulevy@cc.huji.ac.il

Research highlights:

Silicon Photonics
In this work we study the optimization of interleaved Mach-Zehnder silicon carrier depletion electro-optic modulator. Following the simulation results we demonstrate a phase shifter with the lowest figure of merit (modulation efficiency multiplied by the loss per unit length) 6.7V-dB. This result was achieved by reducing the junction width to 200 nm along the phase-shifter and optimizing the doping levels of the PN junction for operation in nearly fully depleted mode. The demonstrated low FOM is the result of both low VπL of ~0.78 Vcm (at reverse bias of 1V), and low free carrier loss (~6.6 dB/cm for zero bias). Our simulation results indicate that additional improvement in performance may be achieved by further reducing the junction width followed by increasing the doping levels. (read more)

Light vapor interactions on a chip
Alkali vapours, such as rubidium, are being used extensively in many important fields of research. Recently, there is a growing effort towards miniaturizing traditional centimetre-size vapour cells. Owing to the significant reduction in device dimensions, light– matter interactions are greatly enhanced, enabling new functionalities due to the low power threshold needed for nonlinear interactions. Here, we construct an efficient and flexible platform for tailored light–vapour interactions on a chip, and demonstrate efficient interaction of the electromagnetic guided mode with absorption saturation at powers in the nanowatt regime. (read more)

Active Silicon Plasmonics
In this work, we experimentally demonstrate an on-chip nanoscale silicon surface-plasmon Schottky photodetector based on internal photoemission process and operating at telecom wavelengths. The responsivity of the nanodetector to be 0.25 and 13.3mA/W for incident optical wavelengths of 1.55 and 1.31 μm, respectively. The presented device can be integrated with other nanophotonic and nanoplasmonic structures for the realization of monolithic opto-electronic circuitry on-chip. (read more)

Plasmonics
Planar plasmonic devices are becoming attractive for myriad applications. Mitigating the challenges of using plasmonics in on-chip configurations requires precise control over the properties of plasmonic modes, in particular their shape and size. Here we achieve this goal by demonstrating a planar plasmonic graded index lens focusing surface plasmons propagating along the device. Focusing and divergence of surface plasmons is demonstrated experimentally. The demonstrated approach can be used for manipulating the propagation of surface plasmons, e.g. for beam steering, splitting, cloaking, mode matching and beam shaping applications (read more)

Metamaterials
The interaction of an incident plane wave with a metamaterial periodic structure consisting of alternating layers of positive and negative refractive index with average zero refractive index is studied. We show that the existence of very narrow resonance peaks for which giant absorption – 50% at layer thickness of 1% of the incident wavelength – is exhibited. Maximum absorption is obtained at a specific layer thickness satisfying the critical coupling condition. This phenomenon is explained by the Rayleigh anomaly and excitation of Fabry Perot modes. (read more)

Plasmonics
Great hopes rest on surface plasmon polaritons’ (SPPs) potential to bring new functionalities and applications into various branches of optics. In this work, we demonstrate a pin cushion structure capable of coupling light from free space into SPPs, split them based on the polarization content of the illuminating beam of light, and focus them into small spots. We also show that for a circularly or randomly polarized light, four focal spots will be generated at the center of each quarter circle comprising the pin cushion device. Furthermore, following the relation between the relative intensity of the obtained four focal spots and the relative position of the illuminating beam with respect to the structure, we propose and demonstrate the potential use of our structure as a miniaturized plasmonic version of the well-known four quadrant detector. (read more)

Silicon Photonics
We demonstrate a nanoscale mode selector supporting the propagation of the first antisymmetric mode of a silicon waveguide. The mode selector is based on embedding a short section of PhC into the waveguide. On the basis of the difference in k-vector distribution between orthogonal waveguide modes, the PhC can be designed to have a band gap for the fundamental mode, while allowing the transmission of the first antisymmetric mode. The device was tested by directly measuring the modal content before and after the PhC section using a near field scanning optical microscope. Extinction ratio was estimated to be ~23 dB. Finally, we provide numerical simulations demonstrating strong coupling of the antisymmetric mode to metallic nanotips. On the basis of the results, we believe that the mode selector may become an important building block in the realization of on chip nanofocusing devices. (read more)

Plasmonics
We experimentally demonstrate the focusing of surface plasmon polaritons by a plasmonic lens illuminated with radially polarized light . The field distribution is characterized by near-field scanning optical microscope. A sharp focal spot corresponding to a zero-order Bessel function is observed. For comparison, the plasmonic lens is also measured with linearly polarized light illumination, resulting in two separated lobes. Finally, we verify that the focal spot maintains its width along the optical axis of the plasmonic lens. The results demonstrate the advantage of using radially polarized light for nanofocusing applications involving surface plasmon polaritons. (read more)
Hebrew University of Jerusalem
Map of hebrew university of jerusalem
////////

REFLECTION PAPER ON NANOTECHNOLOGY-BASED MEDICINAL PRODUCTS FOR HUMAN USE


Nanotechnology

Nanotechnology is the use of tiny structures – less than 1,000 nanometres across – that are designed to have specific properties. Nanotechnology is an emerging field in science that is used in a wide range of applications, from consumer goods to health products.

 

In medicine, nanotechnology has only partially been exploited. It is being investigated as a way to improve the properties of medicines, such as their solubility or stability, and to develop medicines that may provide new ways to:

  • deliver medicines to the body;
  • target medicines in the body more accurately;
  • diagnose and treat diseases;
  • support the regeneration of cells and tissues.

Activities at the European Medicines Agency 

The European Medicines Agency follows the latest developments in nanotechnology that are relevant to the development of medicines. Recommendations from the Agency’sCommittee for Medicinal Products for Human Use (CHMP) have already led to the approval of a number of medicines based on nanotechnology. These include medicines containing:

 

  • liposomes (microscopic fatty structures containing the active substance), such asCaelyx (doxorubicin), Mepact (mifamurtide) and Myocet (doxorubicin);
  • nano-scale particles of the active substance, such as Abraxane (paclitaxel), Emend(aprepitant) and Rapamune (sirolimus).

The development of medicines using newer, innovative nanotechnology techniques may raise new challenges for the Agency in the future. These include discussions on whether the current regulatory framework is appropriate for these medicines and whether existing guidelines and requirements on the way the medicines are assessed and monitored are adequate.

The Agency also needs to consider the acceptability of new testing methods and the availability of experts to guide the Agency’s opinion-making.

 

An overview of the initiatives taken by European Union (EU) regulators in relation to the development and evaluation of nanomedicines and nanosimilars was published in the scientific journal Nanomedicines. The article describes the regulatory challenges and perspectives in this field:

Ad hoc expert group on nanomedicines

In 2009, the CHMP established an ad hoc expert group on nanomedicines.

This group includes selected experts from academia and the European regulatory network, who support the Agency’s activities by providing specialist input on new scientific knowledge and who help with the review of guidelines on nanomedicines. The group also helps the Agency’s discussions with international partners on issues concerning nanomedicines.

The group held the first ad hoc expert group meeting on nanomedicines on 29 April 2009.

 

Reflection papers on nanomedicines

In 2011, the CHMP began to develop in 2011 a series of four reflection papers on nanomedicines to provide guidance to sponsors developing nanomedicines.

These documents cover the development both of new nanomedicines and of nanosimilars (nanomedicines that are claimed to be similar to a reference nanomedicine), since the first generation of nanomedicines, including liposomal formulations, iron-based preparations and nanocrystal-based medicines, have started to come off patent:

The fourth document, a draft reflection paper on the data requirements for intravenous iron-based nanocolloidal products developed with reference to an innovator medicine, will be released for a six-month public consultation in 2013.

International workshops on nanomedicines

The Agency organises workshops on nanomedicines to explore the scientific aspects of nanomedicines and enable the sharing of experience at an international level, in order to assist future developments in the field:

REFLECTION PAPER ON NANOTECHNOLOGY-BASED MEDICINAL PRODUCTS FOR
HUMAN USE

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069728.pdf

Related information

 

 

Share

Nanotechnology, its applications in medicine, pharmaceuticals,drug developments


 

Nanotechnology can be defined as a technology which deals with manipulation, study, and designing and developing particles, bio-molecules of the size more than 1 nm and less than 100 nanometer, with the intention of modification enhancement or lowering a particular property of a molecule or a particle, which can be used in developing a device or molecule

One of the major applications of nanotechnology is in the area of nanoelectronics with MOSFET‘s being made of small nanowires ~10 nm in length. Here is a simulation of such a nanowire.

.Nanotechnology involves developing materials or devices in the size range of 1 nm to 100 nanometer. At this scale quantum mechanical effects have very important implications in the quantum realm; nanotechnology controls the properties of material on an atomic level.

 

 

A serious cause of concern about nanotechnology is its safety and hazardous effects on environment and health, nanomaterial is required to be handled with special care and requires special methods for its disposal.
Drugs that use nanotechnology are also required to qualify for its effectiveness and safety, safety studies are very important factors as so far there is not enough data of drugs developed using nanotechnology and tested for safety.

Nanostructures provide this surface with superhydrophobicity, which lets water droplets roll down the inclined plane.

In pharmaceuticals nanotechnology has wide applications some of which are given below.

1. Targeting a drug to a particular tissue, to, enhancing absorption of a drug molecule in a particular tissue
2. To reduce degradation of a drug and enhance bioavailability and reduce untoward toxic effect of a drug molecule.
3. To enhance the microbial stability of a product
4. In cosmetics zinc oxide nanoparticles are used to increase its antimicrobial properties , and titanium dioxide nano particles effectively block UV rays in both cases concentrations required are very low compared to conventional use.
5. Nanoemulsions for increasing the absorption of a drug molecules.
6. To develop molecules as tracer marker compound to identify the toxic and untoward effects or spilage

Graphical representation of a rotaxane, useful as a molecular switch.

Novel Drugs: Cancer Chemotherapy Using Nanoparticles developed with Nanotechnology May Reduce Harmful Side Effects of Antineoplastic Agents.Chemotherapy for cancer is most of the time associated with one or the other harmful side effect of antineoplastic drugs as these chemotherapeutic drugs themselves are very cytotoxic, i.e. they damage normal cells too.
Antineoplastic drugs bring about their anticancer action by inhibiting cancerour cells growth by virtue of alkylation of nucleotides in cancerous cells or by inhibition of folic acid uptake by cancerous cells or by inhibiting cell division by binding with tubulin and microtubulin in a cancerous cells, it is likely that these drug are also absorbed in to normal tissues, leading to untoward serious cytotoxic effects , like kidney damage and nerve damage in chemotherapy with cisplatin, a drug of choice in most of anticancer chemotherapies.
A new drug delivery technique is being studied which uses Nanotechnology to deliver a cytotoxic drugs specifically directly in to the cancer cells , such drug delivery technique will be able to provide an efficient cancer chemotherapy that do not have much side effects as they pose today , it was observed that with nanoparticle drug delivery system  the concentration of drug required to kill the cancerous cell is lesser than required in conventional chemotherapy therapy.

This DNA tetrahedron is an artificially designed nanostructure of the type made in the field of DNA nanotechnology. Each edge of the tetrahedron is a 20 base pair DNA double helix, and each vertex is a three-arm junction.

As the drug is absorbed efficiently in to targeted cells and also drug is protected from degradation in blood stream , certain class of the anticancerdrugs are very unstable and stay in plasma for a very little time, therefor to achieve the required effect a higher concentration of drug may be required to be administrated.Nanotechnology drug delivery system involves placing an anticancer drug in to a tiny particles known as nanoparticles which recognize cancerous cells and deliver the drug only to cancerous cells , as nanoparticles are very minute particles (1 nm to 100 nanometer) , the dose of drug required to kill the cancerous cells were also found to be very low as compared to conventional therapy . As the required effective dose it self gets reduced than conventional therapy , the harmful effect of anticancer drug are also likely to be reduced.

This device transfers energy from nano-thin layers of quantum wells to nanocrystals above them, causing the nanocrystals to emit visible light.

A team of scientists from the Massachusetts Institute of Technology and Brigham and Women’s Hospital conducted study. They stored an prodrug of cisplatin (which is used in most of cancer chemotherapies) within nanoparticles which they developed to target a specific protein in cancerous cells in prostate gland.
After these prodrug loaded nanoparticles were absorbed by cancerous cells the prodrug was released in to the cancerous cells and was converted in to an active form . The team demonstrated that these prodrug carrying nanoparticles were able to kill cancer cells in culture more efficiently than the drug alone.

Study was conducted by researchers, led by Dr. Omid Farokhzad and Dr. Stephen Lippard, to study nanoparticle drug delivery system for an effective and safer option for chemotherapy in living animals. Their research work is published in Proceedings of the National Academy of Sciences, in Jan 2011 issue of the journal, the study was funded in part by NIH’s National Cancer Institute (NCI) and National Institute for Biomedical Imaging and Bioengineering (NIBIB).

By applying this drug delivery by nanoparticles they were able to shrink tumors in mice with smaller doses of the drug to reduce harmful side effects. Only 30% of the dose of prodrug of cisplatin was required to diminish the tumor by using the drug carrying nanoparticles, than that of standard dose of cisplatin as such.
Researchers initially studied different doses of nanoparticle bound drug in rats and mice, both the types of animals maintained their body weight and survived at higher doses of the drug when drug was delivered using nanoparticles than when injected without nanoparticles. It was also found that the kidney damage was less in rats which received the nanoparticle bound drug.

Also it was found that binding nanoparticles provided greater stability of cisplatin prodrug in blood stream than that of injected alone , after one hour about 77 % of prodrug was found in blood stream when it was delivered using nanoparticles compared to only 16% available drug in case of drug delivered without nanoparticles, cispaltin is very unstable drug and remains in blood for very short time , which calls for more dose to get the desired effect.

 

Transdermal drug delivery system new requirements for quality and for regulatory submissions

 

US FDA issued new guidelines for Transdermal drug delivery system and related drug delivery systems.

US FDA stated in its new guidelines on transdermal drug delivery system and related drug delivery systems that the initial drug load concentration has tremendous potential for impacting quality of product its safety and efficacy and it has great potential for drug abuse.

There are many advantages and disadvantages of transdermal drug delivery system TDDS , like a drug can be administered without pain to patient, patients to like the dosage form greatly as they wont feel as they are on medication, and a constant plasma drug concentration can be easily achieved for a drug for a longer period of time without giving the untoward effect of initial higher plasma level of a drug as in case of conventional dosage forms, also drug escape the first pass metabolism through transdermal drug delivery , some a critical drugs which are known to save life are also administered as Transdermal patches for example nitroglycerin in congestive cardiac diseases.

There are some serious effects observed in resent time, like accidental high dose of a drug up on accidental sticking on handling or accidental contact with skin which has lead individual serious and to fatal conditions some times a life threatening one.

The fatal untoward effects are also seen in health care providers which accidentally handled the patches and got drug dose from remaining drug load from the used transdermal drug delivery patch.

The important factor.

The drug concentration which is required to be loaded on to a Transdermal drug delivery or related drug delivery systems is very high than that of the actual drug being absorbed and required to be achieved in to plasma of a patient.

Nanotechnology cancer treatments would use gold particles to carry anticancer drugs straight to the cancer. Learn about nanotechnology cancer treatments.

 

US FDA guidelines for Transdermal drug delivery patches and related drug delivery systems

In order to finally achieve consistent low residual drug with the desired quality of the Transdermal drug delivery systems ,

1. US FDA requires a drug manufacturers to submit the initial loaded drug concentration in the transdermal drug delivery patch and related drug delivery systems , be provided in the application for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products.

2.US FDA now requires that the all justifications for initial drug load or concentration should be included in the application.

3.It also states that a proper scientific risk based approach must be taken to minimize the drug residue in the system so that a lowest possible concentration remains in the system.

4.The amount of residual drug in the transdemanl drug delivery system must not exceed than those already approved by FDA .

5. US FDA also requires that the information of  product and process development and how the final formulation is justified should be given in the common technical document (CTD) formatted application in section for Pharmaceutical Development.

US FDA has put emphasis on following points

1.) Quality By Design Concept 
2.) Minimizing Residual Drug 

The transdermal drug delivery patches and related products , be developed with the intention of giving efficacy and safety as well,
The quality by design concept basically requires a formulator to plan for a desired quality, quality of a drug can be best achieved when it is planed than when it  monitored.

Planing of quality of a drug product through logical application of past findings and research data and chemistry of drug molecule and exceipients being used, to achieve minimum drug load and this can lead to achieve minimum residual drug in transdermal drug delivery systems after use. Which will ensure that the abuse potential of the transdermal drug delivery systems are taken care of.

Buckminsterfullerene C60, also known as the buckyball, is a representative member of the carbon structures known as fullerenes. Members of the fullerene family are a major subject of research falling under the nanotechnology umbrella.

Nanotechnology and Cancer

Nanotechnology is one of the most popular areas of scientific research, especially with regard to medical applications. We’ve already discussed some of the new detection methods that should bring about cheaper, faster and less invasive cancer diagnoses. But once the diagnosis occurs, there’s still the prospect of surgery, chemotherapy or radiation treatment to destroy the cancer. Unfortunately, these treatments can carry serious side effects. Chemotherapy can cause a variety of ailments, including hair loss, digestive problems, nausea, lack of energy and mouth ulcers.

But nanotechnologists think they have an answer for treatment as well, and it comes in the form of targeted drug therapies. If scientists can load their cancer-detecting gold nanoparticles with anticancer drugs, they could attack the cancer exactly where it lives. Such a treatment means fewer side effects and less medication used. Nanoparticles also carry the potential for targeted and time-release drugs. A potent dose of drugs could be delivered to a specific area but engineered to release over a planned period to ensure maximum effectiveness and the patient’s safety.

These treatments aim to take advantage of the power of nanotechnology and the voracious tendencies of cancer cells, which feast on everything in sight, including drug-laden nanoparticles. One experiment of this type used modified bacteria cells that were 20 percent the size of normal cells. These cells were equipped with antibodies that latched onto cancer cells before releasing the anticancer drugs they contained.

Another used nanoparticles as a companion to other treatments. These particles were sucked up by cancer cells and the cells were then heated with a magnetic field to weaken them. The weakened cancer cells were then much more susceptible to chemotherapy.

It may sound odd, but the dye in your blue jeans or your ballpoint pen has also been paired with gold nanoparticles to fight cancer. This dye, known as phthalocyanine, reacts with light. The nanoparticles take the dye directly to cancer cells while normal cells reject the dye. Once the particles are inside, scientists “activate” them with light to destroy the cancer. Similar therapies have existed to treat skin cancers with light-activated dye, but scientists are now working to use nanoparticles and dye to treat tumors deep in the body.

From manufacturing to medicine to many types of scientific research, nanoparticles are now rather common, but some scientists have voiced concerns about their negative health effects. Nanoparticles’ small size allows them to infiltrate almost anywhere. That’s great for cancer treatment but potentially harmful to healthy cells and DNA. There are also questions about how to dispose of nanoparticles used in manufacturing or other processes. Special disposal techniques are needed to prevent harmful particles from ending up in the water supply or in the general environment, where they’d be impossible to track.

Gold nanoparticles are a popular choice for medical research, diagnostic testing and cancer treatment, but there are numerous types of nanoparticles in use and in development. Bill Hammack, a professor of chemical engineering at the University of Illinois, warned that nanoparticles are “technologically sweet” [Source: Marketplace]. In other words, scientists are so wrapped up in what they can do, they’re not asking if they should do it. The Food and Drug Administration has a task force on nanotechnology, but as of yet, the government has exerted little oversight or regulation.

robotics

A mechanical white blood cell attacks bacteria. The bacteria cannot develop immunity to mechanical devices as it would towards a drug

Nanotechnology, perhaps, has been most popularly recognized for it’s applications in robotics.  Nano-robotics, although having many applications in other areas (such as particle manipulation and, has the most useful and variety of uses in medical fields.

Drugs have been shown to be effective during treatment and so has surgery. However, both are only temporary. We do not have much control over the drugs that have entered our body. As mentioned in the “Applications in Drugs and Therapeutics” page, nanotechnology can play an important role by being used for designing drug delivery systems.

Nanorobots, once fully developed, will be more effective than drugs. This is because nanobots cab always be present in the body, fighting off pathogens such as viruses and tumors. Nanorobots will not require any additional treatment and will become relatively cheap after development.

Some of the potential applications for nano-robotics in medicine include early diagnosis and targeted drug delivery for cancer, biomedical instrumentation, surgery, pharmacokinetics, monitoring of diabetes, and health care. Medical nanotechnology in the future will use nanorobots injected into the patient to perform treatments at cellular levels 

Some other possible applications using medical nanorobots are as follows:

·        To cure skin diseases, a cream containing nanorobots may be used. This cream would remove the right amounts of dead skin cells, remove excess oils which may cause oily skin, insert missing oils, apply the specifically right amounts of natural moisturizing compounds. Dermatological problems would thus be avoided or removed.

·        A mouthwash full of water and smart nanorobots could identify and destroy pathogenic bacteria, particles of food, plaque, or tartar, while allowing the harmless flora of the mouth to flourish. Being suspended in liquid and able to swim about, devices would be able to reach surfaces beyond reach of toothbrush bristles or the floss fibers. As short-lifetime medical nano-devices, the bots could be built to last only a few minutes in the body before falling apart into materials of the sort found in foods (such as fibers and other organic compounds). This would not cause any toxic harmful effects in the body, and there would be no need for toothbrushes.

·        Medical nanodevices could augment the immune system by finding and disabling unwanted bacteria and viruses. When an invader is identified, it can be punctured, letting its contents spill out and ending its effectiveness. If the contents were known to be hazardous by themselves, then the immune machine could hold on to it long enough to dismantle it more completely. With even more innovation, pathogens could be broken down into simple substances such as oxygen and extra cellular material which can be used for benefit of the body!

·        Devices working in the bloodstream could nibble away at arteriosclerotic deposits, widening the affected blood vessels. Various nano-devices could restore the strength of the arteries and veins. With such applications, many heart attacks would be prevented.

More Background on Nanotechnology:

 

bullet Nanotechnology BasicsFor students and other learners
bullet Managing Magic A brief overview of the challenges posed by advanced nanotechnology
bullet Nanotechnology on an Upward Slope An online PowerPoint presentation
bullet Turn on the Nanotech High BeamsAn essay published by Future Brief
bullet Nano SimulationA way to visualize what is meant by molecular manufacturing
bullet Debating the Future of NanotechnologyPerspective from the Foresight Institute
bullet Safe Utilization of Advanced NanotechnologyOne of the founding papers of CRN
bullet 5-Minute Nanosystems A quick summary of Eric Drexler’s foundational work on nanotechnology
bullet Nanotechnology Press KitCompiled and published by Nanotechnology Now
%d bloggers like this: