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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. CONTENTS. Nanotechnology Nanoparticle

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development of nanotechnology based drugs and its guidance

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.

contents
CONTENTS
  • Nanotechnology
  • Nanoparticle
  • Dendrimer
  • Liposomes
  • Micelles
  • Nanoemulsions
  • Nanocrystals
  • Primary Particle
  • Metal Colloids
  • Guidance for Industry Nontechnology Based Products

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definitions
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

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nanotechnology commercialization
Nanotechnology Commercialization
  • Consumer product applications, including cosmetics and sunscreens
  • Food applications, including dietary supplements
  • Medical applications, including drugs and drug delivery devices.

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medical applications
Medical Applications

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nanotechnology
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)

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types of pharmaceutical nanosystems
Types of pharmaceutical nanosystems

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nanoparticle
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.

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nanoparticle1
Nanoparticle

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

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dendrimer
Dendrimer

A polymer in which the atoms are arranged in many branches and subbranches along a central backbone of carbon atoms.

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dendrimer1
Dendrimer

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liposomes
Liposomes

Vesicles composed of one or more bilayers of amphiphatic lipid molecules enclosing one or more aqueous compartments.

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liposomes1
Liposomes

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micelles
Micelles

Self-assembling nanosized colloidal particles with a hydrophobic core and hydrophilic shell currently used for the solubilization of various poorly soluble pharmaceuticals.

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micelles1
Micelles

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nanoemulsions
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.

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nanoemulsions1
Nanoemulsions

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nanocrystals
Nanocrystals

Nanoscale solid formed with a periodic lattice of atoms, ions, or molecules.

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nanocrystals1
Nanocrystals

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primary particle
Primary Particle

Smallest identifiable subdivision in a particulate system.

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primary particle1
Primary Particle

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metal colloids
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.

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metal colloids1
Metal Colloids

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polymer colloids
Polymer Colloids

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guidance for nano industry
Guidance for Nano-Industry
  • Chemistry Manufacturing and Control

II. Human Pharmacokinetics and Bioavailability

III. Labeling

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i chemistry manufacturing and control
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

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description and composition
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.

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physicochemical properties
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

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description of manufacturing process and process control
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.

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control of excipients lipid components
Control of Excipients: Lipid Components
  • Description and Characterization
  • Manufacture
  • Specifications
  • Stability

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control of drug product specifications
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.

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stability
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.

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changes in manufacturing
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.

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ii human pharmacokinetics and bioavailability
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

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bioanalytical methods
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.

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in vivo integrity stability considerations
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.

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protein binding
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.

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in vitro stability
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.

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pharmacokinetics and bioavailability
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

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iii labeling
III. Labeling
  • Product Name
  • Cautionary Notes and Warning
  • Dosage and Administration

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product name
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.
  • Forexample:

BrandX (Acetaminophen) Liposome-Type A For Injection

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cautionary notes and warning
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.

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dosage and administration
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.

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nanotechnology product evaluating questions
Nanotechnology Product Evaluating Questions

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nanotechnology product evaluating questions1
Nanotechnology Product Evaluating Questions

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nanotechnology product review flow chart
Nanotechnology Product Review Flow Chart

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nanotechnology product review flow chart1
Nanotechnology Product Review Flow Chart

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common techniques for characterization
Common Techniques for Characterization
  • Morphology
  • Surface
  • Chemical
  • Others

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morphology
Morphology

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surface
Surface

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chemical
Chemical

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other
Other

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abbreviations
Abbreviations

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thank you e mail nanjwadebk@gmail com cell no 0091 9742431000
THANK YOUE-mail: nanjwadebk@gmail.comCell No: 0091-9742431000

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