These slides use concepts from my (Jeff Funk) course entitled analyzing hi-tech opportunities to show how nanotechnology for drug deliver is becoming economically feasible.
These slides use concepts from my (Jeff Funk) course entitled analyzing hi-tech opportunities to show how nanotechnology for drug deliver is becoming economically feasible.
NANOTECHNOLOGY comprises technological developments on the nanometer scale, usually 0.1 to 100 nm. Nanotechnology, the science of the small. Nano is Greek for dwarf, and nanoscience deals with the study of molecular and atomic particles.
Different types of methods can be used for the preparation of Magnetic Nanoparticles, their advantages and disadvantages and applications of the materials in various fields are given in the presentation
Dynamic light scattering (DLS) or Quasi-Elastic Light Scattering (QELS), is a non-invasive, well-established technique for measuring the size and size distribution of molecules and particles typically in the submicron region, and with the latest technology lower than 1nm.
In This slide the working principle and the function of DLS is Explained in brief and precise way.
Colloidal particles ranging in size between 10 & 1000 nm are known as nanoparticles.
SLNs are new generation of submicron sized lipid emulsion where the liquid lipid(oil) has been substituted by a solid lipid.
Example: Capture - Dior
NANOTECHNOLOGY comprises technological developments on the nanometer scale, usually 0.1 to 100 nm. Nanotechnology, the science of the small. Nano is Greek for dwarf, and nanoscience deals with the study of molecular and atomic particles.
Different types of methods can be used for the preparation of Magnetic Nanoparticles, their advantages and disadvantages and applications of the materials in various fields are given in the presentation
Dynamic light scattering (DLS) or Quasi-Elastic Light Scattering (QELS), is a non-invasive, well-established technique for measuring the size and size distribution of molecules and particles typically in the submicron region, and with the latest technology lower than 1nm.
In This slide the working principle and the function of DLS is Explained in brief and precise way.
Colloidal particles ranging in size between 10 & 1000 nm are known as nanoparticles.
SLNs are new generation of submicron sized lipid emulsion where the liquid lipid(oil) has been substituted by a solid lipid.
Example: Capture - Dior
ABSTRACT
The parenteral administration route is the most effective and common form of delivery for active drug substances with poor bioavailability and the drugs with a narrow therapeutic index. Drug delivery technology that can reduce the total number of injection throughout the drug therapy period will be truly advantageous not only in terms of compliance, but also to improve the quality of the therapy and also may reduce the dosage frequency. Such reduction in frequency of drug dosing is achieved by the use of specific formulation technologies that guarantee the release of the active drug substance in a slow and predictable manner. The development of new injectable drug delivery system has received considerable attention over the past few years. A number of technological advances have been made in the area of parenteral drug delivery leading to the development of sophisticated systems that allow drug targeting and the sustained or controlled release of parenteral medicines.
Introduction
Need of Nanosuspension
Advantages of Nanosuspension
Disadvantages of Nanosuspension
Method Of Preparation
Formulation Considerations
Characterization of Nanosuspension
Current Marketed Formulations
Pharmaceutical Applications
6. INTRODUCTION ABOUT NANOTECHNOLOGY: Nanotechnology is a broad interdisciplinary area of research, development and industrial activity. NANOPARTICLES: Nanoparticles are the end products of a wide variety of physical, chemical and biological processes some of which are novel and radically different, others of which are quite commonplace. Nanoparticles may be defined as submicron (<1µm) colloidal systems, generally, but not necessarily, made of polymers (biodegradable or not).
7. Thus, this term is some what general, since it does not take into account the morphology and structural organization of the system. According to the process used for the preparation of Nanoparticles, Nanospheres or Nanocapsules can be obtained. Nanocapsules are vesicular systems in which the drug is confined to a cavity surrounded by a unique polymeric membrane. Nanospheres are matrix systems in which the drug is dispersed throughout the particles.
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13. Coacervation or Ionic Gelation Method: Much research has been focused on the preparation of nanoparticles using biodegradable hydrophilic polymers such as chitosan, gelatin and sodium alginate. Supercritical Fluid Technology: Supercritical Fluid Technology has been investigated as an alternative to prepare biodegradable micro and nanoparticles because supercritical fluids are environmentally safe. A supercritical fluid can be generally defined as a solvent at a temperature above its critical temperature, at which the fluid remains a single phase regardless of pressure. Supercritical CO 2 is the most widely used supercritical fluid because of its mild critical conditions, non-toxicity, non-flammability and low price.
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15. ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) Currently Marketed Paclitaxel Nanoparticles: DESCRIPTION ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. ABRAXANE is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. ABRAXANE is free of solvents. ABRAXIS BIOSCIENCE Distributed by Abraxis Bioscience, LLC Bridgewater, NJ 08807
16. Preparation for Intravenous Administration: ABRAXANE is supplied as a sterile lyophilized powder for reconstitution before use. AVOID ERRORS, READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION . 1. Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP. 2. Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL. 3. DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this will result in foaming. 4. Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of the lyophilized cake/powder. 5. Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder occurs. Avoid generation of foam. 6. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides.
17. Stability: Unopened vials of ABRAXANE are stable until the date indicated on the package when stored between 20ºC to 25ºC (68ºF to 77ºF), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Stability of Reconstituted Suspension in the Vial: Reconstituted ABRAXANE should be used immediately, but may be refrigerated at 2ºC to 8ºC (36ºF to 46ºF) for a maximum of 8 hours if necessary. If not used immediately, each vial of reconstituted suspension should be replaced in the original carton to protect it from bright light. Discard any unused portion. Stability of Reconstituted Suspension in the Infusion Bag: The suspension for infusion prepared as recommended in an infusion bag should be used immediately, but may be stored at ambient temperature (approximately 25º C) and lighting conditions for up to 8 hours.
18. Drug Profile: Drug Name: Paclitaxel Molecular Formula: C 47 H 51 NO 14 Synonym:Taxol Molecular weight:853.906g/mol Melting point:214.5°C BCS classification: Class IV (Low permeability and Low solubility) Storage: store at 2°C-8°C Solubility: Insoluble in cold and hot water. Bioavailability: 6.5% Protein binding: 89 to 98% Clinical use: Used for Ovarian, breast and lung cancers and also used to treat AIDS related Kaposi’s Sarcoma
19. Polymer Profile: Name: Human Serum Albumin 25% solution Solubility: Soluble in water Storage: Store BUMINATE 25% at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.
20. Method of Preparation of Paclitaxel Nanoparticles: HSA 25% Solution + Chloroform + Paclitaxel (solid form) Formation of Mixture By using Mechanical Stirrer or Magnetic Stirrer In process checks : RPM, Time Formation of Emulsion containing Nanoparticles By using High Shear Mixture In process checks : RPM, Time Formation of Nanoemulsion By using Homogenizer In process checks : Pressure, Cycles (Continuous next slide)
21. Formation of Solvent Free Nanoemulsion By using Rotary Vacuum Evaporator evaporate chloroform In process checks : RPM, Time & Temperature. Filtered Nanoemulsion By using 0.2µm membrane filter, filter Nanoemulsion Formation of Lyophilized cake Lyophilize the Nanoemulsion by using Lyophilizer In process checks : Time (hrs), Vacuum Pressure.