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| PM |
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| Polymeric Micelle (PM) |
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The goal of polymeric micelle technology is to enhance usefulness of water insoluble drugs to the
patients by facilitating formulation into safer and therapeutically more effective products.
Samyang's new biodegradable polymers such as poly(ethylene glycol)-poly(lactic acid) block copolymers
have specific functionality. These polymers have strong potential for the development of self-forming
nanometer-size ( <50nm ) micelle particles which can be administered directly to the specific sites and
release the incorporated or entrapped drug in a sustained manner. Samyang's proprietary polymeric
micelle technology is being evaluated as a potential formulation strategy for systemic or local delivery of
water insoluble candidates.
Testing to date has demonstrated significant pharmaceutical and biological advantages for polymeric
micelle formulations as compared to standard preparations. The technology enables formulation without
employing certain toxic excipients, enhances stability and improves bioavailability of compounds so
formulated. This technology may be applied to a wide range of products for administration by various
routes. Additional potential of the technology may be realized for manipulating pharmacokinetic
parameters and distribution of drug in tissues.
Polymeric micelle technology would also enable companies to improve and differentiate existing products,
enhancing their usefulness and value to patients. |
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| TDS |
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| Transdermal Delivery System (TDS) |
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Transdermal Delivery Systems or patches are applied to skin to allow a well-defined delivery of a potent
drug via skin to impart systemic or local therapeutic effect. The Transdermal Delivery Systems have to be
designed to provide a steady and therapeutically effective concentration of drugs over an extended
period. The Trandermal Drug Delivery Systems not only avoid the gastric and hepatic side effects of
drugs, which appear during chronic treatment using conventional oral formulations, but also provide
steady therapeutic effect over the defined period without fluctuations inherent to other formulations.
Types of Patches
Reservoir type
Reservoir type patches are used to enable transdermal delivery of drugs that can not be formulated into
matrix type patches due to their physical properties or higher therapeutic doses.
Matrix type
Matrix type patches are thin films that contain drugs evenly distributed over the surface as a thin layer in
fine particles or solublised form. The matrix type patches are generally less skin sensitizing in nature than
the reservoir type patches. |
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| FDT |
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| Fast Dissolving Tablet, also called Orally Disintegrating Tablet(FDT) |
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Fast Dissolving Tablets can be dissolved in the mouth rapidly without administering extra water. The FDT
system is suitable for all age groups, but it is especially useful for children, the elderly and schizophrenic
patients who have difficulty in swallowing conventional tablets and capsules. Current technologies
involved in making fast-dissolving tablets include freeze drying, molding, sublimation, and direct
compression. Of these, the direction compaction method is a very attractive one, because it is a
low-cost operation that utilizes conventional tablet equipment, commonly available excipients, and only a
small number of processing steps. Though the manufacturing process is simple, a significant amount
research work was required to develop process that maintains enough porosity inside the compressed
tablets for fast dissolving (or fast melting) while maintaining the mechanically strong tablet property. All
above things considered, we have been engaged in development of FDT technology and our proprietary
FDT system is a modified direct compression method having several features as following:
1. Simple processing
2. Using conventional pharmaceutical facilities
3. Low manufacturing cost
4. Relatively strong in hardness and friability
5. Excellent taste and rapid disintegration
Using this FDT system, several products such as Loratadine, Cetirizine, Aspirin, Tramadol etc. all being
developed. |
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| CSDS |
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| Colonic Specific Drug Delivery System |
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Oral delivery is the most convenient and preferred route of administering drugs. Although this approach
has been greatly successful for numerous drug entities, yet many other drugs that are incompatible with
the physical and/or chemical environments of the gastrointestinal(GI) tract and/or demonstrate poor
uptake in the stomach, duodenum, or small intestine provide poor therapeutic benefits when given in
conventional oral dosage forms. The poorly absorbed drugs, an important class of which are peptides,
and proteins, are primarily given by parenteral routes.
Rectal delivery of such drugs has been proposed and tested but has failed to gain favor among the
general population or decision makers of the pharmaceutical industry. Interest, therefore, has now
shifted toward assessing the potential of another region of the GI tract, the colon, as a site for drug
delivery using novel oral formulations.
The colon demonstrates a longer residence time, reduced enzymatic activities, and greater
responsiveness to agents that enhance the absorption of poorly absorbed drugs when compared to the
upper GI tract. Colon delivery is, naturally, the most effective site for the local treatment of the large
intestinal diseases with reducing side effects.
The Samyang's colonic drug delivery (SY-CSDS) technology based on polysaccharides is designed to be
degraded by the bacteria in the colon, whilst remaining refractory to the environment of the upper GI
tract. The System's design is based in part on principles of human colonic microflora which produce
b-D-glucosidase, b-D-galactosidase, amylase, pectinase, xylanase, b-D-xylosidase, and dextranase that
hydrolyze polysaccharides only in the colon.
The SY-CSDS technology consists of a proprietary formulation of saccharidic biodegradable hydrogels, in
the form of film, which can protect an incorporated drug until it reaches the colon to provide controlled
delivery. The conventionally formulated core tablets or capsules coated with SY-CSDS polymeric film has
been shown to pass intact through the upper GI tract after oral administration. Upon reaching colon the
hydrolysis of the polymer's glycosidic bonds by specific enzymes present in colon occurs. It is thought
that the increase in the porosity of film leads to spatial drug release in the colon from SY-CSDS dosage
forms.
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| POLIGOGEL |
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SYC's patented novel drug delivery system allows once a week delivery of protein drugs like interferon,
G-CSF and other peptides. The in vitro and in vivo studies have confirmed the presence of active drug in
therapeutic concentrations for 5-7 days after injection. The system is easy to adapt for manufacture and
the biopolymers used have been tested for toxicity.
Contrary to the pegylation technology used for weekly delivery of G-CSF etc., our technology does not
require development as a "new drug". Poligogel is a "drug delivery system" in true sense. |
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| PoligoGel |
1. Native Protein formulation
(Protein + polymer + Water)
2. Sustained Release
3. Protein release & polymer degradation follow same
time curve(thus no interference with next dose)
4. Suitable for all protein drugs
5. Regulatory requirement :
clinical development
6. Patented system |
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