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PES
MODERN COLLEGE OF PHARMACY (Ladies)
MOSHI, PUNE
Savitribai Phule Pune University
B.PHARM
Semester- VII
By
Mrs. Sneha Patil
Assistant Professor
Dept. of Pharmaceutics
Introduction to
platform technology
Content
1. Introduction
2. Importance of platform technology
3. Examples of platform technology
4. New technology platforms/capabilities
5. Pathway for development of platform technology
6. References
2
1. Introduction
 Definition – a common or standard method, equipment,
procedure or work practice that may be applied across multiple
products under development or manufacture
 It is valuable tool to improve efficiency and quality in drug
product development
 Platform enables a continuous improvement by adding data for
every new molecule developed by this approach, increasing the
strength of the platform
3
2. Importance of platform technology
 It helps companies to improve customer experience
 Improve the process for all stakeholders
4
3. Examples of platform technology
1. Nanotechnology
 Employing nanosize particles to deliver drugs to specific type of
cells e.g. cancer cells
 Particles are engineered so that they are attracted to diseased
cells, which allow direct treatment of those cells
2. Microsphere technology
 To develop differentiated formulations for targeted delivery
 Aim – site specific action to eliminate repeated dosing and to
decrease side effect
3. Liposomal technology
 Selectively target drugs for optimizing pharmacokinetic
parameters, pharmacological effect and reduce toxicity e.g.
Amphotericin B 5
Examples of platform technology continue…..
4. Hot melt extrusion technology
 Used to produce molecular dispersions with considerable
advantages over solvent based processes e.g. spray drying
and co-precipitations
 Used to provide SR (sustained release), modified and targeted
drug delivery
5. SR formulations technology
 Ex. Osmotic controlled release oral delivery system (OROS)
formulated in tablet formulations
6. Multiple unit pellet system technology
 Used to develop SR tablets
 Tablets are made of multiple particulates that disintegrate into
individual pellets and provide sustained drug release 6
Examples of platform technology continue…..
7. Orally disintegrating (OD) formulations technology
 Used to develop OD tablets that disintegrate rapidly when
placed upon the tongue and ensure faster onset of action
 Patient convenience and compliance
8. Inhalations technology
 Advantages in therapy of diseases of the respiratory tract
 Faster action as compared to orally administered product
 Ex. Metered dose inhalers, dry powder inhalers (unit dose –
rotahaler, revolizer; multidose – multii haler), autohaler (steroid
and long acting  agonist), nasal sprays
9. Effervescent technology
 Formulating effervescent tablets to provide quick relief along
with taste masking effects
7
Examples of platform technology continue…..
10. Sprinkles
 Oral granule formulation specially designed for paediatric
patients
 They can be sprinkled over a child’s food which makes the drug
palatable e.g. Anti- HIV therapy
11. Stem cell based products
 Large scale production of adult mesenchymal cells from bone
marrow for therapeutic applications
12. Magnetic targeted carriers (MTCs)
 They are microparticles (0.5 mm to 5 mm) composed of metallic
iron (75%) and activated carbon (25%)
8
4. New technology platforms/capabilities
 Argos therapeutics – Immunotherapy platform for treating a
range of cancers
 Assembly biosciences – Targeted, dual release delivery to the
GI tract
 Celsion – Tumor targeting technology for heat sensitive
liposome
 Sirenas - Speeding discovery and development of marine
inspired therapeutics
 Phenotypic drug screening platform
 Structure based and fragment based drug design technology
platform
 Computation and informatics technology platform
9
New technology platforms/capabilities continue…..
 Translational pharmacology technology platform, patient ferived
xenograft (PDX) model
 Novel biologics
10
5. Pathway for development of platform
technology
A. Selection of candidate drug
1. Solubility/Dose
2. Stability
3. Lipophilicity/ permeability
4. Elimination half life (t1/2)
5. Therapeutic window
6. First pass metabolism
7. PK/PD realtionship
11
Pathway for development of platform technology continue……
B. Selection of polymers
1. Material used for matrix systems - hydrophilic polymers ;
crosslinked homoplymers and copolymers of acrylic acid,
insoluble polymers
2. Material used for reservoir systems
3. Polymer used for osmotic pump system - e.g. Cellulose
acetate
12
Pathway for development of platform technology continue……
C. Design and development of platform technology
 Factors influencing the selection of CR technology
1. Match between technology attributes and physicochemical and
biopharmaceutical properties of drug candidate
2. Ease of adapting to a paediatric formulation
3. Manufacturing factors, including prior experience with the
technology
4. Inhouse processing expertise
5. Availability of commercial scale equipment and robustness of
performance on scale up
13
Pathway for development of platform technology continue……
D. Development process
1. Tabletting process
2. Spheronization/ pelletization process
3. Coating technologies
14
6. References
1. Veena Kalyyani S., Mohammed younus Ali. Industrial
pharmacy II. Nirali publication, Pune; 2020, Pg. no. 1.44-1.49
2. Hajare A.A., Industrial pharmacy II. Nirali publication, Pune;
2020, Pg. no. 1.41-1.43
15
16

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Introduction to Platform technology.ppt

  • 1. PES MODERN COLLEGE OF PHARMACY (Ladies) MOSHI, PUNE Savitribai Phule Pune University B.PHARM Semester- VII By Mrs. Sneha Patil Assistant Professor Dept. of Pharmaceutics Introduction to platform technology
  • 2. Content 1. Introduction 2. Importance of platform technology 3. Examples of platform technology 4. New technology platforms/capabilities 5. Pathway for development of platform technology 6. References 2
  • 3. 1. Introduction  Definition – a common or standard method, equipment, procedure or work practice that may be applied across multiple products under development or manufacture  It is valuable tool to improve efficiency and quality in drug product development  Platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the strength of the platform 3
  • 4. 2. Importance of platform technology  It helps companies to improve customer experience  Improve the process for all stakeholders 4
  • 5. 3. Examples of platform technology 1. Nanotechnology  Employing nanosize particles to deliver drugs to specific type of cells e.g. cancer cells  Particles are engineered so that they are attracted to diseased cells, which allow direct treatment of those cells 2. Microsphere technology  To develop differentiated formulations for targeted delivery  Aim – site specific action to eliminate repeated dosing and to decrease side effect 3. Liposomal technology  Selectively target drugs for optimizing pharmacokinetic parameters, pharmacological effect and reduce toxicity e.g. Amphotericin B 5
  • 6. Examples of platform technology continue….. 4. Hot melt extrusion technology  Used to produce molecular dispersions with considerable advantages over solvent based processes e.g. spray drying and co-precipitations  Used to provide SR (sustained release), modified and targeted drug delivery 5. SR formulations technology  Ex. Osmotic controlled release oral delivery system (OROS) formulated in tablet formulations 6. Multiple unit pellet system technology  Used to develop SR tablets  Tablets are made of multiple particulates that disintegrate into individual pellets and provide sustained drug release 6
  • 7. Examples of platform technology continue….. 7. Orally disintegrating (OD) formulations technology  Used to develop OD tablets that disintegrate rapidly when placed upon the tongue and ensure faster onset of action  Patient convenience and compliance 8. Inhalations technology  Advantages in therapy of diseases of the respiratory tract  Faster action as compared to orally administered product  Ex. Metered dose inhalers, dry powder inhalers (unit dose – rotahaler, revolizer; multidose – multii haler), autohaler (steroid and long acting  agonist), nasal sprays 9. Effervescent technology  Formulating effervescent tablets to provide quick relief along with taste masking effects 7
  • 8. Examples of platform technology continue….. 10. Sprinkles  Oral granule formulation specially designed for paediatric patients  They can be sprinkled over a child’s food which makes the drug palatable e.g. Anti- HIV therapy 11. Stem cell based products  Large scale production of adult mesenchymal cells from bone marrow for therapeutic applications 12. Magnetic targeted carriers (MTCs)  They are microparticles (0.5 mm to 5 mm) composed of metallic iron (75%) and activated carbon (25%) 8
  • 9. 4. New technology platforms/capabilities  Argos therapeutics – Immunotherapy platform for treating a range of cancers  Assembly biosciences – Targeted, dual release delivery to the GI tract  Celsion – Tumor targeting technology for heat sensitive liposome  Sirenas - Speeding discovery and development of marine inspired therapeutics  Phenotypic drug screening platform  Structure based and fragment based drug design technology platform  Computation and informatics technology platform 9
  • 10. New technology platforms/capabilities continue…..  Translational pharmacology technology platform, patient ferived xenograft (PDX) model  Novel biologics 10
  • 11. 5. Pathway for development of platform technology A. Selection of candidate drug 1. Solubility/Dose 2. Stability 3. Lipophilicity/ permeability 4. Elimination half life (t1/2) 5. Therapeutic window 6. First pass metabolism 7. PK/PD realtionship 11
  • 12. Pathway for development of platform technology continue…… B. Selection of polymers 1. Material used for matrix systems - hydrophilic polymers ; crosslinked homoplymers and copolymers of acrylic acid, insoluble polymers 2. Material used for reservoir systems 3. Polymer used for osmotic pump system - e.g. Cellulose acetate 12
  • 13. Pathway for development of platform technology continue…… C. Design and development of platform technology  Factors influencing the selection of CR technology 1. Match between technology attributes and physicochemical and biopharmaceutical properties of drug candidate 2. Ease of adapting to a paediatric formulation 3. Manufacturing factors, including prior experience with the technology 4. Inhouse processing expertise 5. Availability of commercial scale equipment and robustness of performance on scale up 13
  • 14. Pathway for development of platform technology continue…… D. Development process 1. Tabletting process 2. Spheronization/ pelletization process 3. Coating technologies 14
  • 15. 6. References 1. Veena Kalyyani S., Mohammed younus Ali. Industrial pharmacy II. Nirali publication, Pune; 2020, Pg. no. 1.44-1.49 2. Hajare A.A., Industrial pharmacy II. Nirali publication, Pune; 2020, Pg. no. 1.41-1.43 15
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