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  • Slide 1 - 15/04/ 2012 1 Development of Nanotechnology -Based Drugs and its Guidance Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph.D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM-590010 E-mail: nanjwadebk@gmail.com Cell No: 00919742431000 FDP on Nanotechnology, VTU, Belgaum.
  • Slide 2 - 15/04/ 2012 2 CONTENTS Nanotechnology Nanoparticle Dendrimer Liposomes Micelles Nanoemulsions Nanocrystals Primary Particle Metal Colloids Guidance for Industry Nontechnology Based Products FDP on Nanotechnology, VTU, Belgaum.
  • Slide 3 - 15/04/ 2012 3 Definitions Nanomaterial/Nanoscale Material: Any material with at least one dimension smaller than 100 nm. Nanomedicine: The use of nanoscale materials for medical applications Characterization: Physicochemical evaluation of relevant drug properties FDP on Nanotechnology, VTU, Belgaum.
  • Slide 4 - 15/04/ 2012 4 Nanotechnology Commercialization Consumer product applications, including cosmetics and sunscreens Food applications, including dietary supplements Medical applications, including drugs and drug delivery devices. FDP on Nanotechnology, VTU, Belgaum.
  • Slide 5 - Medical Applications 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 5
  • Slide 6 - Nanotechnology The understanding and control of matter at dimensions between approximately 1 to 100 nanometers, where unique phenomena enable novel applications. (Source: National Nanotechnology Initiative Definition) 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 6
  • Slide 7 - Types of pharmaceutical nanosystems 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 7
  • Slide 8 - Nanoparticle Nano-object with all three external dimensions at the nanoscale that is the size range from approximately 1 nm to 100 nm. Polymeric nanoparticle platforms are characterized by their physicochemical structures including solid nanoparticles, nanoshell, dendrimer, polymeric micelle, and polymer-drug conjugates. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 8
  • Slide 9 - Nanoparticle 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 9 TEM (a, b, and c) images of prepared mesoporous silica nanoparticles with mean outer diameter: (a) 20nm, (b) 45nm, and (c) 80nm. SEM (d) image corresponding to (b). The insets are a high magnification of mesoporous silica particle
  • Slide 10 - Dendrimer A polymer in which the atoms are arranged in many branches and subbranches along a central backbone of carbon atoms. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 10
  • Slide 11 - Dendrimer 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 11
  • Slide 12 - Liposomes Vesicles composed of one or more bilayers of amphiphatic lipid molecules enclosing one or more aqueous compartments. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 12
  • Slide 13 - Liposomes 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 13
  • Slide 14 - Micelles Self-assembling nanosized colloidal particles with a hydrophobic core and hydrophilic shell currently used for the solubilization of various poorly soluble pharmaceuticals. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 14
  • Slide 15 - Micelles 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 15
  • Slide 16 - Nanoemulsions Emulsions with droplet size in the nanometer scale. Emulsion is a thermodynamically unstable system consisting of at least two immiscible liquid phases, one of which is dispersed as globules (the dispersed phase), in the other liquid phase (the continued phase), stabilized by the presence of an emulsifying agent. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 16
  • Slide 17 - Nanoemulsions 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 17
  • Slide 18 - Nanocrystals Nanoscale solid formed with a periodic lattice of atoms, ions, or molecules. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 18
  • Slide 19 - Nanocrystals 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 19
  • Slide 20 - Primary Particle Smallest identifiable subdivision in a particulate system. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 20
  • Slide 21 - Primary Particle 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 21
  • Slide 22 - Metal Colloids Metal nanoparticles in colloidal systems where the term colloidal refers to a state of subdivision. This implies that the molecules or polymolecular particles are dispersed in a medium and have at least in one direction a dimension roughly between 1 nm and 1μm or, in a system, have discontinuities at distances of that order. For example, silver, gold, titanium dioxide, zinc oxide, and iron oxide. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 22
  • Slide 23 - Metal Colloids 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 23
  • Slide 24 - Polymer Colloids 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 24
  • Slide 25 - Guidance for Nano-Industry Chemistry Manufacturing and Control II. Human Pharmacokinetics and Bioavailability III. Labeling 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 25
  • Slide 26 - I. Chemistry Manufacturing and Control Description and Composition Physicochemical Properties Description of Manufacturing Process and Process Control Control of Excipients: Lipid Components Description and Characterization Manufacture Specifications Stability E. Control of Drug Product: Specifications F. Stability G. Changes in Manufacturing 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 26
  • Slide 27 - Description and Composition The components of liposome drug products are the drug substance, the lipids, and other inactive ingredients. The pharmacological and toxicological properties and the quality of these drug products can vary significantly with changes in the formulation, including the lipid composition. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 27
  • Slide 28 - Physicochemical Properties Morphology of the liposome, including lamellarity determination, if applicable Volume of entrapment in liposomal vesicles Particle size (mean and distribution profile) Phase transition temperature Spectroscopic data, as applicable In vitro release of the drug substance from the liposome drug product osmotic properties light scattering index 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 28
  • Slide 29 - Description of Manufacturing Process and Process Control Liposome drug products are sensitive to changes in the manufacturing conditions, including changes in scale. If there are changes in critical manufacturing parameters, complete characterization of the liposome drug product is recommended and in vivo studies may be warranted. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 29
  • Slide 30 - Control of Excipients: Lipid Components Description and Characterization Manufacture Specifications Stability 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 30
  • Slide 31 - Control of Drug Product: Specifications Physicochemical parameters of the liposome determined to be critical to product quality for each batch. Assay for encapsulated and unencapsulated (i.e., free) drug substance. Degradation products related to the lipids. Assay of lipid components. In vitro test for release of drug substance from the liposome. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 31
  • Slide 32 - Stability The physical stability of liposome drug products is a function of the integrity and the size distribution of the lipid vesicles. Liposomes are susceptible to fusion, aggregation, and leakage of the encapsulated drug substance during storage. Liposome drug products should be evaluated for stability of the encapsulated drug substance as well as stability of the lipids that compose the liposomal bilayer. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 32
  • Slide 33 - Changes in Manufacturing Liposome drug products are a relatively new dosage form, it is not possible to provide recommendations on the type of information that should be generated to demonstrate that the change has not adversely affected the quality of the drug product. The extent of the information and documentation to be developed and submitted to support a change should depend on the types of manufacturing changes and the stage of manufacturing at which the changes occur. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 33
  • Slide 34 - II. Human Pharmacokinetics and Bioavailability Bioanalytical Methods In Vivo Integrity (Stability) Considerations Protein Binding In Vitro Stability Pharmacokinetics and Bioavailability Mass Balance Study Pharmacokinetic Studies Additional Pharmacokinetic Studies Food-Effect Studies Drug Interactions and /or Special Populations Exposure-response Studies 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 34
  • Slide 35 - Bioanalytical Methods Validated bioanalytical methods should be used when evaluating the pharmacokinetics and bioavailablity of a drug substance. For liposome drug products the bioanalytical method should also be capable of measuring encapsulated and unencapsulated drug substance. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 35
  • Slide 36 - In Vivo Integrity (Stability) Considerations In addition to the general stability considerations of the drug substance in a biological fluid, the stability of the liposome in vivo should be considered. A single-dose study is recommended to assess the in vivo stability of the liposome. The concentration-time profile should be evaluated at multiple time points over an adequate period of time. The concentration of encapsulated and unencapsulated drug substance should be determined at each sampling time point. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 36
  • Slide 37 - Protein Binding The stability of liposomes in vivo can be affected by interactions with lipoproteins and other proteins in the blood. Interactions of liposomes with serum proteins and lipoproteins can be dependent on the type of lipids used in formulating the liposomes. The protein (including lipoprotein) binding of the drug substance and liposome drug product should be determined over the expected therapeutic concentration range. The major binding proteins should be identified. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 37
  • Slide 38 - In Vitro Stability An in vitro test that measures the release of the drug substance from the liposome can be important for assessing the (1) Quality of a liposome drug product, (2) Adequacy of the process controls, (3) Release characteristics of the product over time, and (4) The effect of CMC changes e.g., minor manufacturing process changes or change in site of manufacture. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 38
  • Slide 39 - Pharmacokinetics and Bioavailability Mass Balance Pharmacokinetic Studies Additional Pharmacokinetic Studies a. Food-Effect Studies b. Drug Interaction and /or special Populations c. Exposure-Response Studies 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 39
  • Slide 40 - III. Labeling Product Name Cautionary Notes and Warning Dosage and Administration 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 40
  • Slide 41 - Product Name The product name should include the established name, dosage form, terminology to describe that it is a liposome drug product, and, if desired, a proprietary (i.e., brand) name. The descriptive terminology should include the term liposome and, when appropriate, such terms as Type A, Type B, and Type C, to distinguish one liposome product from other liposomal formulations of the same drug substance that are not therapeutically equivalent. For example: BrandX (Acetaminophen) Liposome-Type A For Injection 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 41
  • Slide 42 - Cautionary Notes and Warning A cautionary note should be included in the description section of the labeling regarding the fact that liposome drug products may behave differently from nonliposome drug products. A warning should be included in the labeling that the liposome drug product is not equivalent to or cannot be substituted for other drug products containing the same drug substance. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 42
  • Slide 43 - Dosage and Administration This information should be provided for both unloaded lyophilized liposomes that are reconstituted with a drug substance-containing solution at the time of use, as well as products in which the drug substance is loaded into the liposome by the manufacturer and then lyophilized. Other issues that should be addressed, as warranted, include storage conditions for the reconstituted drug, robustness of the liposome drug product under varied reconstitution conditions (e.g., degree of shaking), and appropriateness of using in-line filters. 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 43
  • Slide 44 - Nanotechnology Product Evaluating Questions 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 44
  • Slide 45 - 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 45 Nanotechnology Product Evaluating Questions
  • Slide 46 - Template for CDER Nanotechnology Drug Product Database Entry 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 46
  • Slide 47 - Nanotechnology Product Review Flow Chart 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 47
  • Slide 48 - Nanotechnology Product Review Flow Chart 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 48
  • Slide 49 - Common Techniques for Characterization Morphology Surface Chemical Others 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 49
  • Slide 50 - Morphology 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 50
  • Slide 51 - Surface 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 51
  • Slide 52 - Chemical 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 52
  • Slide 53 - Other 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 53
  • Slide 54 - Abbreviations 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 54
  • Slide 55 - THANK YOU E-mail: nanjwadebk@gmail.com Cell No: 0091-9742431000 15/04/ 2012 FDP on Nanotechnology, VTU, Belgaum. 55

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