PHARMACEUTICAL AND COSMETIC PRODUCT
DEVELOPMENT (MPH 204T) Detailed Notes – [Link]
Pharmaceutics (Semester II, PCI Syllabus)
UNIT 1: PREFORMULATION STUDIES
Definition: Preformulation is the phase of research and development in which physicochemical
properties of a drug substance are characterized to design stable, safe, and effective dosage
forms.
1. Objectives:
To establish compatibility with excipients.
To identify ideal formulation conditions.
To improve bioavailability and stability.
2. Parameters studied:
Physical properties: Particle size, shape, flow properties,
polymorphism.
Chemical properties: Solubility, pKa, partition coefficient,
hygroscopicity.
Drug-excipient compatibility: Determined using DSC, DTA, TGA, IR
spectroscopy, and TLC.
Crystallinity and polymorphism: Different crystal forms may alter
solubility and stability.
3. Additives and excipient selection:
Diluents: Lactose, MCC, starch.
Binders: PVP, gelatin.
Lubricants: Magnesium stearate.
Disintegrants: Sodium starch glycolate.
4. New developments in excipient science:
Co-processed excipients (e.g., Ludipress, Prosolv).
Multifunctional excipients combining flow and binding properties.
UNIT 2: SOLUBILITY
Definition: Solubility is the concentration of solute that can dissolve in a solvent under specific
conditions.
1. Importance:
Influences dissolution, absorption, and bioavailability.
2. Factors affecting solubility:
Temperature, pH, particle size, crystalline form, and solvent polarity.
3. Solubility enhancement techniques:
Cosolvency: Using mixed solvents like ethanol, PEG, glycerin.
Salt formation: Suitable for ionizable drugs.
Complexation: Inclusion complexes with cyclodextrins.
Solid dispersions: Drug dispersed in polymers like PVP, PEG.
Micellar solubilization: Surfactants (SLS, Tween 80).
Hydrotropy: Addition of hydrotropic agents like sodium benzoate.
4. Analytical methods:
Phase solubility analysis, HPLC, UV spectroscopy, XRD.
UNIT 3: PRODUCT STABILITY
Definition: The capability of a drug product to remain within its physical, chemical,
microbiological, and therapeutic specifications.
1. Mechanisms of degradation:
Hydrolysis: Common in esters, amides, lactams.
Oxidation: Occurs in unsaturated compounds; prevent with
antioxidants.
Photolysis: Light-induced degradation.
Racemization: Conversion of optically active forms.
2. Stability testing:
Real-time: 25°C ± 2°C / 60% RH ± 5%.
Accelerated: 40°C ± 2°C / 75% RH ± 5%.
3. Data interpretation:
Follows zero-order or first-order kinetics.
Shelf life (t90) = 0.105 / k (first-order reaction).
4. ICH Guidelines:
ICH Q1A: Stability Testing of New Drug Substances and Products.
UNIT 4: HERBAL COSMETICS
Definition: Cosmetics formulated using herbal or plant-derived ingredients.
1. Common herbal ingredients:
Hair care: Amla, Bhringraj, Hibiscus, Reetha.
Skin care: Aloe vera, Turmeric, Neem, Sandalwood.
Oral care: Clove oil, Miswak, Neem bark.
2. Standards and regulations:
COSMOS and ECOCERT certifications for natural products.
Use of preservatives approved by BIS.
3. Formulation components:
Emollients (coconut oil), emulsifiers (lecithin, beeswax), rheology
modifiers (xanthan gum).
4. Challenges:
Standardization, microbial contamination, short shelf life.
UNIT 5: COSMETICS – FORMULATION, MANUFACTURING &
QUALITY CONTROL
1. Hair care products:
o Shampoo: Surfactants (SLS), conditioners (polyquaternium),
fragrance, preservative.
o Hair dye: Para-phenylenediamine (PPD), oxidation base,
stabilizers.
2. Oral care products:
o Toothpaste: Abrasives (calcium carbonate), fluoride, flavoring
agents.
o Mouthwash: Alcohol, antiseptic (chlorhexidine), menthol.
3. Skin care products:
o Creams: Emulsions with oil and water phases.
o Foundation creams: Contain pigments, UV filters, humectants.
4. Manufacturing equipment:
o Planetary mixers, homogenizers, tube fillers, filling machines.
5. Quality control tests:
o pH, viscosity, spreadability, microbial load, stability.
o Safety: Patch test, ocular irritation test.
6. Regulatory aspects:
o Cosmetic Rules 2020, labeling (product name, manufacturer,
expiry), banned ingredients.
QUICK REVISION SUMMARY
QbD: QTPP, CQA, CPP, CMA
Solubility enhancement: solid dispersion, cosolvency, hydrotropy.
Stability: ICH Q1A, shelf life formula.
Herbal cosmetics: Aloe vera, Neem, Bhringraj.
Cosmetics QC: pH, viscosity, microbial limit, labeling.
Prepared and summarized by: Bhaskar Chowdary Chundru