Standardization of drug, ORGANOLEPTIC EVALUATION, MICROSCOPIC EXAMINATION,DETERMINATION OF FOREIGN MATTER, DETERMINATION OF ASH, DETERMINATION OF HEAVY METALS, MICROBIAL CONTAMINANTS, DETERMINATION OF PESTICIDE RESIDUES, DETERMINATION OF RADIOACTIVE CONTAMINATION, PHYTOCHEMICAL PROFILES- FINGERPRINTING, MULTIPLE MARKER- BASED FINGER PRINTING, Curcumin, Microbiology specification for species, Compound formulation, Herbal formulations, TRADITIONAL DOSAGE FORMS, MODERN HERBAL DOSAGE FORMS, NOVEL DRUG DELIVERY STEMS (NDDS)/ NOVEL DOSAGE SYSTEM, SYRUP, MIXTURE, TABLET, LIPOSOME, Curcumin, NIOSOMES, PRONIOSOMES, NANOPARTICLES, ETHOSOMES, MARKETED HERBAL NOVEL DRUG DELIVERY FORMULATIONS,

1. 1
PRESENTED BY
S R BHARATHKUMAAR(19BIOB04)
II M Sc., BIOTECHNIOLOGY
2019-2021
DEPT OF BIOTECHNOLOGY,
BHARATHIAR UNIVERSITY,
COIMBATORE.

2. STANDARDIZATION
Standardization of drug means confirmation of its identity,
quality and purity throughout all phases of its cycle i. e., shelf-
life, storage, distribution and use by various parameters.
Facilitate commoditization of formerly custom processes.
2

3. STANDARDIZATION OF HERRBAL DRUGS
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4. BOTANICAL
PHYSICAL
CHEMICAL
BIOLOGICAL
ORGANOLEPTIC
• Colour
• Odour
• Taste
• Texture
• Fracture
Macroscopic Microscopic
• Shape
• External
• marking
• Qualitative
• Quantitative
• SEM studies
• Powder studies
• Moist cont
• Extract values
• Ash values
• Fluores analy
• Qualitative
• Quantitative
• Chromatography
• Heavy metal
• Pesticide residue
• Mycotoxin
Microbial
contamination
• Toxicological
• Pharmacological
• Other specific
activities
Antagonistic
• Bacterial
• Fungal
4

5. ORGANOLEPTIC EVALUATION
• Authentic specimen, pharmacopoeial quality samples
• Simplest &quickest means- identity and purity
MICROSCOPIC EXAMINATION
• Ensures plant of the required species
DETERMINATION OF FOREIGN MATTER
• Entirely free from moulds, stones or insects producing
toxins
• Macroscopic examination, TLC (Chemical residue)
5

6. DETERMINATION OFASH
• Total ash and insoluble ash
• Amount of silica present, esp. in the form of sand &
siliceous earth
DETERMINATION OF HEAVY METALS
• Based on colour reactions with special reagents
(thioacetamide/ diethyidiocarbamate)
• Atomic Absorption Spectrophotometry (AAS), Inductively
Coupled Plasma (ICP), Neutron Activation Analysis (NAA)
MICROBIAL CONTAMINANTS
• Poor methods- harvesting, cleaning, drying etc.
• Total aerobic microbial/fungal/ Enterobacteriaceae counts,
tests for E.coli, S.aureus, Shigella, P.aeruginosa and
salmonella spp
6

7. DETERMINATION OF PESTICIDE RESIDUES
• Accumulate from agricultural practices
• Has Cl2 in the molecule
• Extracted by SOP, impurities removed by partition
and /or adsorption and individual pesticides measured
by GC, MS, or GC/MS
DETERMINATION OF RADIOACTIVE
CONTAMINATION
• Due to nuclear accident
• No limits proposed
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9. STANDARDIZATION
 Preliminary testing- different chemical groups
 Quantification of chemical group of interest
 Establishment of fingerprint mobiles
 Multiple marker- based finger print profiles
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10. Qualitative &Semi-
quantitative
information
Quantification of
chemical constituents
Rapid analysis of
herbal extracts with
minimum sample
clean-up requirement
PHYTOCHEMICAL PROFILES- FINGERPRINTING
• FINGERPRINTING USING HPLC& GLC USING SPECIFIC CASES
10

11. TLC METHOD
STEP 1
• Preparation of drug extracts for analysis
STEP 2
• Adsorbent: TLC silica gel plate (60 F254, 10x10 cm)
• Screening system: suitable solvents
• System A: EA: CH3 OH water (100:13:5:10)- Polar
compounds
• System B: Toluene EA (93.7): Liphophilic compounds
STEP 3
• Detection
• UV 254 nm: quenching zones ( Conjugated double bonds); UV 365 nm-
fluorescent zones
• Spray reagents- 10% ethanolic KOH reagent
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12. FINGERPRINTING PROFILES- TLC& HPTLC
12

13. MULTIPLE MARKER- BASED FINGER PRINTING
Active principles
• Vasicine, curcumin, E and Z- guggulsterones
Chemical markers
• Hederagenin, curcubitacins, rutin, quercetin
General markers
• Gallic acid, lupeol, stigmasterol, β- sitosterol
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MULTIPLE MARKER- BASED EVALUATION
TLC HPLC HPTLC
Phyllanthin,
hypophyllanthin, Gallic
acid, Ellagic acid-
Phyllanthus amarus
Four triterpenic acids-
Terminalia arjuna
Piperine- Piper,
Glycyrrhizin-
Glycyrrhiza, Allicin-
Allium sativum

15. PREFERRED METHOD: HPTLC
Crude samples containing multi-components
Two dimensional separations easy
Choice of solvents
Several samples separated parallel- low cost
Minimizes exposure risk of toxic organic effluents
Uses specific and sensitive colour reagents
Different modes of evaluation
Microbial activity in spots assessed
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Curcumin:
 Turmeric color is attributed primarily to a group of related compounds
designated as Curcuminoids with curcumin.
 Prinicipal component admixed with its two derivative
 Demothoxycurcumin
 Bisdemethoxycurcumin
 Spectrophotometric method for quantification of curcumin.
 HPLC has emerged as an efficient tool for the quantification of individual
curcuminoids.

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ASTA cleanliness specifications for turmeric
Parameter Upper limit
Whole insects, dead (by count) 3
Excreta, mammalian (by mg/lb) 5
Excreta, other (by mg/lb) 5.0
Mold (% by weight) 3.00
Insect defiled/ infested (%by weight) 2.50
Extraneous foreign matter (% by
weight)
0.50

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Microbiology specification for species
Parameter Standard value Danger value
Total aerobic bacteria 10 5 /g 10 6/g
E. coli Absent absent
Bacillus cerus 10 4 /g 10 5 /g
Staphylococcus aureus 100/g 1000/g
Salmonella Absent in 25g Absent in 25g
Sulfite reducing clostrides 10 4/g 10 5 /g
Controlling microorganisms
The microbial load in herbs and species can be controlled by three techniques
• Steam sterilization
• Fumigation
• Irradiation

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Pesticide residues:
• Chemical residues at various in plant growth results in accumulation of their
residue in species.
Aflatoxins:
• Aflatoxins are a group of secondary metabolites of the fungi
• Aspergillus falvus
• Aspergillus parasticus
• Aflatoxins in species are generally classified into four categories
B1, B2, G1, G2
Heavy metals:
• Lead, cadmium, arsenic and mercury are major concern. Atomic absorption
spectroscopy is recommended as the standard method for the analysis.
• Limits specified forsome trace metals in whole and ground turmeric under the
Indian standards

21. OTHER METHODS
SUPERCRITICAL
FLUID
CHROMATOGRAPHY
DNA FINGER-
PRINTING
GENETIC
MARKER
21

22. 22

23. HERBAL FORMULATION
Herbal formulations means a dosage form consisting of one
or more herbs or processed herbs in specified quantities to
provide specific nutritional, cosmetic benefits meant for use to
diagnose, treat, mitigate diseases of human beings or
animals, alter the structure or physiology of human beings or
animals.
Herbal formulations are obtained by subjecting herbal
substances to treatments such as extraction, distillation,
expression, fractionation, purification, concentration or
fermentation include comminuted or powdered.
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24. Traditional dosage forms
Modern herbal dosage forms
Novel dosage forms
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25. Traditional systems of medicines like
Ayurveda, Unani, Homeopathy
Eg. Pills, Powders, Semi fluid extracts,
Pellets, Tinctures etc..
1. TRADITIONAL DOSAGE FORMS
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26. 1. Developed from modern
technological process
2. Formulations offers small dosage
3.User friendly, convenient and
have good absorption
characteristics
Eg. Tablets, Capsules, Syrups,
Suppositories, Injection
2. MODERN HERBAL DOSAGE FORMS
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27. 3. NOVEL DRUG DELIVERY STEMS (NDDS)/ NOVEL DOSAGE SYSTEM
Advancement in different scientific
techniques of preparing formulations
Developed to overcome the limitations of
conventional dosage forms such as tablets,
syrups solutions etc..
Many (ND )forms have been developed
successfully which have offered better
acceptance by the health system
Few (ND) forms available in the market are
transdermal patches, implants, nasal systems,
microcapsules, microspheres, liposomes,
phytosomes, etc..
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28. HERBAL FORMULATIONS
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29. SYRUP
Definition:
Sweet, visicious, concentrated aqueous solutions of sucrose or other sugars
(dextrose, sorbitol, glycerin and propylene glycol). Sucrose is partly hydrolyzed into
reducing sugars, levulose and dextrose.
• This help in retarding oxidation.
Types:
Simple syrup
Medicated syrup
Flavoring syrup
Artificial syrup
Dry syrup
Ingredients:
• Sugar, anti-microbial agents/ preservatives, flavorant, colorant.
• Syrup I.P is a 66.7% w/v solution of sucrose whereas USP is 85% w/v solution of
sucrose. When the concentrated of the sucrose in the syrup is low then, the
preservatives is added like methyl paraben, benzoic acid, sodium benzoate,
alcohol
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30. METHODS OF PREPARATION:
Hot process (for substances neither volatile nor heat labile): weighed sucrose +
purified water = heat. Strain and if required make up volume with boiled purified
water Eg. Syrup IP, Acacia syrup NF, and Tolu syrup IP
Percolation (cold process, syrup USP preparation method): Sucrose in percolator
and allow to pass purified water slowly through sucrose. The neck of the
percolator is packed with loosely compressed cotton. Rate of percolation the rate
of dissolution of sucrose.
Addition of a medicating or flavoring liquid to syrup: When fluid extracts,
tinctures or other liquids are to be added to syrup. Alcohol also acts as a
preservative.
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31. Agitation without heat (for heat-labile constituents): sucrose and other
ingredients if + purified water = add in bottle = through agitation (for shaking
manual or mechanical agitators) of bottle.
Preservation and storage
• Store at a temperature not exceeding 25⁰C
• Store in well dried, completely filled and carefully stoppered bottles in a cool
dark place
Evaluation
• Physical appearance ( color, odor, taste), pH, weight per ml , viscosity and
Stability study
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32. MIXTURE
Definition:
A mixture is a liquid preparation meant for oral administration in which
medicament or medicaments are dissolved, suspended or dispersed in a suitable
vehicle. Although “mixture” term is also used for “suspension”.
Advantages:
Easy to administer
Suitable for insoluble drug
Suitable for immiscible drug
More bioavailability compared to solid dosage form
Disadvantages:
More incompatibilities
Less stable
Expensive
Tedious storage and transport
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33. TYPES
Simple mixture containing soluble
substances
Drug + vehicle
Mixture containing diffusible solids Do not dissolve in water, but on shaking
they can be mixed Eg., Rhubarb root
Powder
Mixture containing in-diffusible solids Reduce the settling of practices the
viscosity of the mixture is increased by
adding some thickening agents like gum
acacia, targacanth or compound
targacanth powder or their mucilage
Eg., Aromatic chalk powder
Mixture containing precipitate forming
liquids
Protective colloid is dispersed in the
vehicle before tincture is added.
Eg., Myrrh Tincture, Tolu Tincture
Mixture containing colloidal particle Drug is added with alkali like NaOH and
mix by the hydration to form colloidal
mixture Eg., Milk of magnesia 33

34. STORAGE:
Plain glass bottles with uniform internal diameter
Suitable removable cork to prevent spilling of mixture
EVALUATION:
Physical appearance (color, odor, taste), pH, weight per ml, viscosity and
stability study
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TABLET
Definition:
Tablets are the solid unit dosage forms containing a medicament or
mixture of medicament and excipients ( Diluents, Blinders, Lubricants,
Disintegrators, Wetting agents) compressed or molded into solid cylindrical shape
having either flat or convex surface.
Types:
Mono-herbal or poly herbal tablets
Compressed tablets
Sugar coated tablets
Film coated tablets
Enteric coated tablets
Effervescent tablets
Chewable tablets
Dispersible tablets
Sustained release tablets
Sublingual tablets
Troches
Buccal tablets
Hypodermic tablets
Vaginal tablets
Solution tablets

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METHOD OF PREPARATION:
Wet granulation method: Oldest and most widely used method involving steps
weighing, mixing, granulation, screening the damp mass, drying, drying
screening, lubrication, finally compression.
Dry granulation method: (Slugging, double compression or recompression
method) for ingredients sensitive to moisture or elevated temperature during
drying. Essential steps: weighing, mixing, slugging, dry screening, lubrication and
compression.
Direct compression: For a small group of crystalline chemicals. Simple absence
of granulating step, avoidance of moisture and drying steps, minimal material
handling, rapidity of the total process and optimum possible bioactive of the
drugs from the resulting tablets
EVALUATION PARAMETERS
Physical nature, Content of active ingredient, Uniformity, Friability,
Hardness, Disintegration, Dissolution test

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NOVEL DRUG DELIVERY SYSTEM
VESICULAR
CARRIERS
LIPOSOMES
NICOSOMES
ETHOSOMES
TRANSFEROSOMES
EMULSOMES
PHYTOSOMES
INVASOMES
MICELLAR
CARRIERS
POLYMERIC
MIXED
PHOSPHOLIPID
BASED
PARTICULATE
CARRIERS
SOLID LIPID
NANOPARTICLES
NANOSTRUCTURED
LIPID CARRIERS
POLYMERIC NANO
PARTICLES
EMULSIFIED
CARRIERS
MICROEMULSIONS
NANOEMULSIONS
LIPID EMULSION

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DRAWBACKS OF CONVENTIONAL DOSAGE FORMS
Poor patient compliance and missing those of drug
Fluctuation in drug concentration lead to under medication or over medication
and thus side effects
ADVANTAGES OF NOVEL DRUG DELIVERY SYSTEM
Enhancement of solubility
Increased bioavailability
Protection from toxicity
Enhancement of pharmacological activity
Enhancement of stability
Sustained delivery
Protection from chemical and physical degradation

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LIPOSOME
• Liposome meaning lipid body, broadly describes as a small vesicles of a
bilayer of a phospholipid encapsulating an aqueous space ranging from about
0.03 to 10µm.
• Generally the lipid membrane of liposome consists of bilayer forming
amphiphile, cholesterol and a charge generating molecule.
Advantages:
 The high biocompatibility
 The easiness of preparation
 The chemical versatility that allows the loading of hydrophilic, amphiphilic
and lipophilic compounds
 The simple modulation of their pharmcokinetic properties

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• The lipid membrane encloses a
discrete aqueous compartment
• Both hydrophilic and hydrophobic
drugs can be delivered using liposomal
formulations.(amphiphilic nature)
• The mode of incorporation of the drug
depends upon the polarity of the drug.
• Hydrophilic drugs are encapsulated in
the aqueous core of the liposomes whereas
hydrophobic drugs are entrapped in the
phospholipid bilayer
• Liposomes have been administered
parentally, topically and by inhalation.

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Curcumin

43. 43
NIOSOMES
Niosomes are multi-lamellar vesicles formed from non-ionic surfactants of
the alkyl or dialkylpolyglycerol ether class and cholesterol
Liposomes face problems such they are
expensive, their ingredients such as
phospholipids are chemically unstable
because of their predisposition to
oxidative degradation, they require
special memory and handling and
purity of natural phospholipids is variable.
Niosomes do not have any of these problems
PRONIOSOMES
Proniosomes (alternative to liposome) gel system is step forward to niosome
It can be utilized for various applications in delivery of active at desired site.
Proniosomes gels are the formulation, which are converted into niosome on
in situ hydration (absorbing water from the skin are converted into
niosome).

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NANOPARTICLES
Nanoparticles are efficient delivery systems for the delivery of both hydrophilic
and hydrophobic drugs
Nanoparticles are the submicron
sized particles, ranging 10-1000 nm.
Can control particle size, surface
properties and release of
pharmacologically active agents
Site specific action of the drug at the
therapeutically optimal rate and
dose regimen.
• Eg.: Berberine nanoparticle; Anticancer for sustained drug release.
• Curcuminoids solid lipid nanoparticle ; Anticancer and antioxidant for
prolonged release of the Curcuminoids

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ETHOSOMES
Newer advancements in the patch technology have led to the development of
ethosomal patch, which consists of drug in ethosomes
Ethosomal systems are made up of soya phosphatidylcholine, ethanol and
water
They may form multi-lamellar vesicles and have a high entrapment capacity
for particles of various lipophilicities.

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MARKETED HERBAL NOVEL DRUG DELIVERY FORMULATIONS
Two companies dominate the market for these systems, namely
Cosmetochem and Indena
Cosmetochem launches HerbasecR technology
Include liposomal preparations of various herbal ingredients such as extracts
of White tea, Green tea, White hibiscus, Gurana and Aloe Vera
Indena patented technology of pytosomes. Indena commercializes the plant
extracts of liquorice (visnadin), Centella asiatica, G. biloba, green tea, grape
seed etc..

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SHOWIS OVER
YOUMAY NOWRELAX