Transfersome

Transfersome is a trademark registered by the German company IDEA AG, which refers to its proprietary drug delivery technology. The name means “carrying body” and is derived from the Latin word 'transferre', meaning 'to carry across', and the Greek word 'soma', meaning 'a body'. A Transfersome carrier is an artificial vesicle designed to exhibit the characteristics of a cell vesicle or a cell engaged in exocytosis, and thus suitable for controlled and, potentially, targeted drug delivery.


Discovery

The term Transfersome and the underlying concept were introduced in 1991 by Gregor Cevc. Numerous groups have since been working with similar carriers, frequently using different names (e.g., elastic vesicle, flexible vesicle, Ethosome, etc.) to describe them.
In a broader sense, a Transfersome is a highly adaptable, stress-responsive complex aggregate. The form preferred by researchers and pharmacologists is an ultradeformable vesicle possessing an aqueous core surrounded by the complex lipid bilayer. Interdependencies inherent in the local composition and shape of the bilayer makes the vesicle both self-regulating and self-optimizing. This enables the Transfersome to cross various transport barriers efficiently, and then act as a Drug carrier for non-invasive targeted drug delivery and sustained release of therapeutic agents.

Characterisation

The mechanical properties and transportability of a vesicle can be studied by measuring stress- or deformation-dependent vesicle bilayer elasticity and changes in permeability. In a single experiment, the objective may be reached by determining the pressure dependent area density of the Transfersome suspension flux through a nano-porous filter, with pores at least 50% smaller than the average vesicle size. For the proper Transfersome vesicles, the proportionality function derived by the experiment, so-called “Penetrability”, increases non-linearly with the flux driving force (head pressure), often sigmoidally). The bulk suspension viscosity governs the highest achievable penetrability; a suspension of ideal Transfersome vesicles, experiencing no friction in the barrier, therefore yields a similar maximum penetrability value as the comparably tested vesicles-suspending fluid. On the other hand, the characteristic pressure needed to achieve a significant transport rate with the vesicles suspension mainly depends on the adaptability of the bilayer being evaluated. Analysis of experimental Penetrability vs. Driving pressure curves can therefore yield the characteristic bilayer elasticity and permeability values, based on a theoretical description of material flow as an activated transport process.

Usage

Transfersome technology is best suited for non-invasive delivery of therapeutic molecules across open biological barriers where Transfersome vesicles can transport molecules that are too big to diffuse through the barrier. Examples include systemic delivery of therapeutically meaningful amounts of macromolecules, such as insulin or interferon, across intact mammalian skin. Other applications include the transport of small molecule drugs which have certain physicochemical properties which would otherwise prevent them from diffusing across the barrier.

Manufacturing

Transfersome vesicles are prepared in a similar manner as liposomes, except that no separation of the vesicle-associated and free drug is required. Examples includesonicating,[1] extrusion, low shear rates mixing (multilamellar liposomes), or high high-shear homogenisation unilamellar liposomes) of the crude vesicle suspension.

Novel Drug Approvals for 2016

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
No.Drug 
Name
Active IngredientApproval DateFDA-approved use on approval date
9.Tecentriqatezolizumab5/18/2016To treat urothelial carcinoma, the most common type of bladder cancer
Press Release
8.Nuplazidpimavanserin4/29/2016To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease
Press Release
7.Venclextavenetoclax4/11/2016For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Press Release
Drug Trials Snapshot
6.Defiteliodefibrotide sodium3/30/3016To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation
Press Release
Drug Trials Snapshot
5.Cinqairreslizumab3/23/2016To treat severe asthma
Press Release
Drug Trials Snapshot
4.Taltzixekizumab3/22/2016To treat adults with moderate-to-severe plaque psoriasis. 
Press Release
Drug Trials Snapshot
3.Anthimobiltoxaximab3/18/2016To treat inhalational anthrax in combination with appropriate antibacterial drugs.
Press Release
Drug Trials Snapshot
2.Briviactbrivaracetam2/18/2016To treat partial onset seizures in patients age 16 years and older with epilepsy.
Press Release
Drug Trials Snapshot
1.Zepatierelbasvir and grazoprevir1/28/2016To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
Press Release
Drug Trials Snapshot

8 new Drug molecules from India

  • Two decades after Indian Pharma started dabbling in new drug research, eight indigenously developed novel drugs are gearing up for late-stage human trials.While two new molecules are being developed by BioCon and Glenmark each, the others are contributed by Dr.Reddy’s, Sun, Ranbaxy and Primal life sciences.
    Dr Reddy’s anti-diabetic drug, codenamed DRF 2593-307, was the first indigenously developed novel drug to enter phase-III trials, in August 2007. This is the penultimate round of testing on patients before marketing approval can be sought. Last year, two more compounds made it to this stage: Biocon’s oral insulin pill and Ranbaxy’s anti-malaria drug. A fourth drug, from Glenmark, to treat diarrhoea, is concurrently undergoing phase-II and phase-III trials.


1) IN-105 (Biocon)
  • Therapy area: Diabetes-insulin
  • Status: In phase-III human trials
  • Target launch: 2011 in India; rest of the world by 2015
  • Global market size: $13 billion
  • Global players: Novo Nordisk, Eli Lilly
2) T1h (Biocon)
  • Therapy area: Psoriasis & rheumatoid arthritis
  • Status: Completed phase-II trials
  • Target launch: Not yet announced
  • Global market size: $15-16 billion
  • Global players: Astellas, BMS, Abbot, Amgen
3) DRF 2593-307IN (Dr Reddy’s Lab)
  • Therapy area: Diabetes-PPAR agonists
  • Status: In phase-III trials
  • Target launch: Not announced yet
  • Global market size: $7 billion
  • Global players: Glaxo, Takeda, Abbot, Solvay
4) Crofelemer (Glenmark Pharma)
  • Therapy area: Diarrhoea
  • Status: In phase-III trials
  • Target launch: 2010-11
  • Global market size: $2-3 billion
  • Global players: Glaxo
5) Sun-1334H (Sun Pharma)
  • Therapy area: Allergy
  • Status: Completed phase-II trials
  • Target launch: Not Announced Yet
  • Global market size: $5.5 billion
  • Global players: Sanofi-Aventis, Pfizer
6) GRC 8200 (Glenmark Pharma)
  • Therapy Area: Diabetes-DPP IV inhibitor
  • Status: Completed phase-II trials
  • Target launch: 2013-14
  • Global market size: $1-2 billion
  • Global players: Merck
7) P276 (Primal Life sciences)
  • Therapy area: Cancer
  • Status: Late phase-II trials
  • Target launch: To file for marketing approval in 2011
  • Global market size: $47.7 billion
  • Global players: Roche, Eli Lilly, Pfizer, Glaxo
8) Arterolane Maleate+Piperaquine Phosphate (Ranbaxy)
  • Therapy area: Malaria
  • Status: Currently in phase-III trials
  • Target launch: To apply for marketing approval by late-2010
  • Global market size: Less than $1 billion
  • Global players: Novartis
In spite of lower costs of operating in India, R&D of new drug molecules is a long, tiring and expensive affair. The Indian companies have invested in drug molecules especially required in India ( like drugs for malaria, Diabetes, Diarrhoea). The fate of these 8 molecules may well decide future R&D plans of Indian Pharma companies. 
Related articles;-

Psoriasis Diseases

Psoriasis: The Basics
*Psoriasis is a chronic multisystem disease with predominantly skin and joint manifestations

*Affects approximately 2% of the U.S. population

*Age of onset occurs in two peaks: ages 20-30 and ages 50-60, but can be seen at any age

*Waxes and wanes during a patient’s lifetime, is often modified by treatment initiation and cessation and has few spontaneous remissions

*There is a strong genetic component
#Classification of Psoriasis

Classification is based on morphological descriptions

The types of psoriasis are:
Plaque: scaly, erythematous patches, papules, and plaques that are sometimes pruritic

Inverse/Flexural: lesions are located in the skin folds

Erythrodermic: generalized erythema covering nearly the entire body surface area with varying degrees of scaling

Pustular: clinically apparent pustules

•are, acute generalized variety called "von Zumbuschvariant"

•Palmoplantar–localized involving palms and soles
 
Guttate: presents withdrop lesions, 1-10mm salmon-pink papules with a fine scale

Clinical findings in patients frequently overlap in more than one category

Different types of psoriasis may require different treatment

GuttatePsoriasis
 
Acute onset of raindrop-sized lesions on trunk and extremities in young adults, often preceded by streptococcal pharyngitis
Inverse/Flexural Psoriasis
 
Erythematous plaques in the axilla, groin, inframammary region, and other flexural areas. May lack scale due to moistness of area. 

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