The growing field of Personalized therapy and newer approaches for dosage forms related to Personalization for the safe and effective treatment of patients. The field of personalized medicine aims at converting the term of "one drug fits all " approach to Personalized therapy. Thus, shifting emphasis in medicine from reaction to prevention.

1. Dosage Forms for
Personalized Medicine
Presented by:
Songhita Mukhopadhyay
Reg No.180603003
MPharm Pharmaceutics
Dept.of Pharmaceutics
Under the guidance of:
Shaila Angela Lewis
Associate Professor-Senior Scale
Dept.of Pharmaceutics

2. Contents
• Personalized medicine: Emergence
• Need for Personalized medicine
• Pharmacogenomics and Gene testing
 Pharmacogenomics
 Pharmacogenetic tests
• Categories of patients for personalized medicine
• Dosage forms
• Recent advances in the field of personalized
medicine
• Personalized medicine in India
• Key gaps and barriers
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3. Personalized Medicine: Emergence
• Variability in drug response
• individual drug therapy.
• predictive outcome
• Pharmacogenetics
• molecular underpinnings of drug response.
• patient’s gene variations
• selection of drugs or treatment protocols
• Personalized medicine (PM)
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5. Need for Personalized Medicine
• Patient care
 early diagnosis
 risk assessment
 cost effective
• Device and drug manufacturers
 develop agents
 targeted to patient groups
 do not respond to medications as intended
 the traditional health systems have failed.
• hospitals, health care providers, and health plan
sponsors
 Innovation
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6. Can PM be referred to as
simple medicine?
• Treat diseases by molecular profiles
• linked databases
• patients’ genomic information
• pay for tests and treatments
• genetic tests
• safety and efficacy of an approved drug
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7. Pharmacogenomics and Gene Testing
• Pharmacogenetics- genetic variations in individuals
• affect their response to medications.
• Pharmacogenomics- broader study
• genetic variations
• drug development.
• Studying sequence variations in candidate genes.
• Identify disease susceptibility genes
• representing potential new drug targets.
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12. Pharmacogenomics: Heart of
Personalized Medicine
• Better medication selection.
• Safer dosing options
• Improvements in drug development
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14. Pharmacogenetic tests
• Drug-metabolizing enzyme allele tests,
• single nucleotide polymorphism (SNP) analysis.
• Tests of gene expression and
• tests for non-heritable (somatic) mutations
• Microarray testing
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20. Dosage forms
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21. • Fast-Dispersing, fast dissolving or
fast melting tablets:
Difficulty in swallowing.
Eg. Olanzapine and risperidone- Fast dissolving-
conventional tabletting-Frosta TM system-freeze
drying.
Floss method-fibrous matrix made from mix of
excipients-FLASHDOSE R- Fuisz Technologies
Zydis TM- Selegiline- R.P. Scherer
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22. • Oral film technology:
Systemic medicines to be delivered in thin strip.
Polymer coatings containing API for transdermal
drug delivery-transition to oral thin film.
Aqueous polymer matrices- wide molecular range-
flexibility to achieve certain physical properties.
Specific API loading.
Disintegrates on a patient’s tongue- matter of
seconds.
Eg.Theraflu (Dextromethorphan) and
Triaminic(Diphenhydramine HCl) thin strips by
Novartis Consumer Health Care
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23. • Combination Dose System:
Two or more regulated components-
Combination of drug and device
biological product and device
drug and biological product
drug, device and biological product.
Eg. HIV treatment include Combivir TM (Zidovudine
and lamivudine) (GSK)
Pfizer’s Caduet TM (Amlodipine and atorvastatin)
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24. • Mini-Tablets:
Matrix mini tablets based on starch/ microcellulose
wax mixtures.
Different dose levels can be administered-changing
number of mini tablets within a capsule for adults
or using single units for children.
Possible to utilize fast-dissolving mini-tablets to
prepare liquid dosages.
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25. Three Dimensional Printing:
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26. 3DP- Breakaway tablet
Tablet breaks up into two parts after dissolution of
the fixative joining the parts together.
Useful in combination therapy where relative doses
need to be varied according to the patient.
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27. • Microdose systems:
Potent drugs to be administered.
Solid drug forms incorporated into micro or
nanoparticles- drug in volatile solvent- microdoses
can be applied to the matrix.
Films- RapidFilm TM-water soluble polymers such
as HPMC, HPC, and PVP- drugs incorporated into
the system-matrix forms platform-loading of drugs
at will.
Drug release- passive- dissolution of the matrix or
dissolution of the drug or a combination of
processes.
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28. • Microfluidic devices and
microchip-based technologies:
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29. Pharmacogenomic studies of oral
antidiabetic drugs
• T2DM patients
• similar requirements of antidiabetic regimens
• variability exists in drug disposition, glycemic
response, tolerability
• during treatment
• Pharmacogenomics
• Non-genomic modifications
• Pharmacoepigenomics
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30. Whole-genome sequencing
methods in familial cancer
• FCVPPv2 (Family Cancer Variant Prioritization
Pipeline version 2).
• Family with history of a papillary thyroid cancer.
• one variant, amino acid change G573R
• CPXM1 gene
• adipogenesis and extracellular matrix
remodelling
• tumour suppressor in breast cancer.
• prediction of predisposing variants for high-risk
cancer families.
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32. Personalized Medicine in India
• Young but rapidly advancing field of healthcare.
• Positive Bioscience with Medanta
India’s first personal genomics clinic
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• Start-up company Xcode Lifesciences
• InDNA technology
• coronary, diabetes and obesity.
• Order the test online
• saliva kit will be shipped to the customer.
• DNA extracted from the saliva
allelic information.

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• NutraGene
• country’s first commercial
genetic test for type 2
diabetes.
• Screens DNA variations
• replicated as risk factors for
type 2 diabetes.
• Avesthagen
• AVESTAGENOME Project.
• System biology-based study of the
Parsi population
• determine the genetic basis of
longevity and
• age-related disorders.

34. Key gaps and barriers
• Millions of genetic variations may exist.
• how one person responds to a medication- many
genes interacting with each other.
• Complicated genetic map
• Expensive and time-consuming.
• Pharmacogenomic testing not yet widely available
and it remains an uncertain science.
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35. References
• Randy Vogenberg F et.al-Personalized medicine: Part 1:Evolution and Development into
Theranostics; P T. 2010 Oct; 35(10).
• Mancinelli L et.al-Pharmacogenomics: The Promise of Personalized Medicine; AAPS PharmSci
2000; 2 (1) Article 4.
• Eichelbaum M et.al- PHARMACOGENOMICS AND INDIVIDUALIZED DRUG THERAPY; Annu. Rev.
Med. 2006. 57:119–37.
• Modern Pharmaceutics-Vol 2 –Application and advances by Florence and Siemann; Drugs and
Pharmaceutical Sciences- 5th edition-Vol 189; Marcel Dekker.
• Vangelis G et.al-Pharmacogenomics of oral antidiabetic medications: current data and
pharmacoepigenomic perspective; Future Medicine Ltd Pharmacogenomics (2011) 12(8), 1161–
1191.
• Kumar A et.al-Familial Cancer Variant Prioritization Pipeline version 2 (FCVPPv2) applied to a
papillary thyroid cancer family; Scientific Reports (2018) 8:11635.
• Vondrak B et.al Dissolvable films for flexible product format in drug delivery. Pharm Technol
Suppl 2008 (April) (www.pharmtech.com).
• De Brabander C, et.al. Matrix minitablets based on starch/microcellulose wax mixtures. Int J
Pharm 2000; 199:195-203.
• Huang W, et.al. Levofloxacin implants with predetermined microstructure fabricated by thee
dimensional printing. Int J Pharm 2007; 339:33-38
• http://persalth.com/personalized-medicine/personalized-medicine-in-india/personalized-
medicine-in-india/
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