Elaboração de Shampoo - Projeto Integrador

Main Ideas / Concepts Taught

• Purpose of the integrative project: Students were originally asked to do a technical observational visit to a compounding pharmacy. Since not everyone could participate, the instructor taught the process through a live stream so students could still gather information/evidence (e.g., photos) for their APA document.
• Two shampoo formulations are demonstrated:
  1. Daily-use gentle shampoo (base formulation)
  2. Anti-dandruff shampoo with 2% ketoconazole (therapeutic formulation)

Characteristics of a Good Shampoo (Quality Requirements)

A shampoo should have:

• Enough lather/foam, though lather amount is not a direct measure of cleaning strength.
• The right viscosity for easy dispensing and application.
• Acidic pH stability and compatibility with water-based use.
• Ingredients that are not harsh/irritating to hair or eyes.
• Easy rinse to avoid residue and support detangling/combability.
• Acceptable appearance, color, and scent (marketing/consumer acceptance).

Shampoo Base Composition (Component Categories)

• Vehicle: water (where actives are incorporated)
• Surfactants
• Foam stabilizers
• Superfatting agents
• Agents with specific properties
• Formulation stabilizers (e.g., preservatives like methylparaben)
• Character modifiers / marketing attributes: dye/color, opacifying agent, fragrance
• Other functional materials: chelators, viscosity regulators, pH regulators, humectants/conditioning agents, etc.

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Method / Step-by-Step Workflow (Practical Methodology)

A) Safety and Preparation for Compounding Practice

• Tie hair back.
• Wear:
  • Cap
  • Mask
  • Gloves
  • Lab coat
  • Long pants
  • Closed shoes

B) General Formulation Logic (Water / QSP to Reach Final Volume)

• Formulas are presented in phases (A, B, C).
• Target batch size: 100 mL
  • If changing batch size, use the rule of three.

• To determine Phase C water (QSP):

  • Add up all weighed components across phases A and B, plus any non-water components.
  • Exclude the “SP/QSP” water portion from the sum.

  • Then calculate:

    • Water in Phase C = 100 mL − (sum of other ingredients)

  • Weigh/measure that exact amount of deionized water.

C) Gentle Daily-Use Shampoo (Base Shampoo) — Phase Approach

Phase Structure: A / B / C

• Phase A: surfactant system components (example materials mentioned)

  • Lauryl ether sulfate (sodium salt)
  • Sodium lauryl sulfoxinate
  • Cocamidopropyl betaine

• Phase B:

  • Lauryl polyglucoside (described as pasty)
  • Coconut fatty acid ethanolamine
  • Methylparaben (preservative)
  • Sodium chloride (viscosity regulator)
  • Sodium EDTA (chelating agent)

• Phase C:

  • Deionized water to reach final volume (QSP)

Practical Steps

• Heat/melt ingredients in the appropriate phase if needed (e.g., warmer plate/heating aid).
• Solubilize methylparaben in Phase B using gentle heating.
• Combine phases in order:
  1. Combine Phase A components into a beaker/cup base.
  2. Add melted/solubilized Phase B carefully.
  3. Prepare Phase C: dissolve EDTA in water, then dissolve sodium chloride in that solution.
  4. Combine Phase C with Phase A/B slowly to reduce foaming and ensure final volume accuracy.
• Homogenize gently:
  • Avoid aggressive stirring because surfactants cause excess foaming, which makes final volume adjustment inaccurate.
• pH adjustment to ~6:
  • Measure pH with a pH meter (keep the tip wet; clean with soft paper).
  • If pH is too high/basic, lower it using 10% anhydrous citric acid solution, added dropwise while homogenizing.
  • Recheck until reaching target (demonstrated around 6.0–6.2, then adjusted to 6.0).

Quality Control Outcomes / Student Tasks

Students were instructed to complete an APA table including:

• What each ingredient category does (e.g., water = vehicle, sodium chloride = viscosity, methylparaben = preservative).
• Identify the main cleaning component and explain its cleaning mechanism (surfactants reduce surface tension and help remove oils/residues).

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D) 2% Ketoconazole Anti-Dandruff Shampoo — Phase Approach

Key Differences vs. Base Shampoo

• Active ingredient: ketoconazole (2%) for antifungal anti-dandruff effect.
• pH target: adjusted to about 5.5 (as demonstrated).
• Uses citric acid initially to help solubilize ketoconazole, then switches to the base formulation for pH correction.

Practical Steps

• Compute Phase C water (QSP) the same way (target 100 mL, subtract the sum of non-water components).
• Phase A: solubilize ketoconazole using a measured citric acid solution
  • Example given: 3 mL of 10% citric acid solution
  • Mix into a paste-like form, then blend until dissolved enough for incorporation.
• Phase B: prepare preservative and conditioning/surfactant components
  • Methylparaben in emollient/conditioning base components (as demonstrated)
  • Additional surfactants/conditioning agents (e.g., cocamidopropyl betaine and other components listed)
• Phase C: dissolve EDTA/other solubilized stabilizer components (where applicable) and add deionized water to the measured final volume.
• Combine phases slowly and mix gently to minimize foaming.

pH Adjustment to 5.5

• After ketoconazole solubilization with citric acid, pH may be low (demonstrated around 4.9).
• Raise pH with 1 M sodium hydroxide solution:
  • Add dropwise, homogenize, and re-measure with the pH meter.
  • Continue until reaching 5.5.

Therapeutic / Marketing and Student Assignments

Students filled tables to:

• Identify ketoconazole as the active ingredient and its function.
• Provide the class/mechanism of action and indications.

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Key Lessons About Ingredients (Roles and Classifications)

Surfactants (Core Cleaning Agents)

• Reduce water surface tension and help remove fatty acids, sweat, dust, and residues.
• Surfactant structure:
  • Polar (hydrophilic) head: water-soluble
  • Nonpolar (hydrophobic) tail: water-insoluble
• Classified by head charge:
  • Anionic: deeper cleansing
  • Cationic: hair softening, gentler cleansing
  • Non-ionic: lighter cleaning (“more ecosystem-focused”)
  • Amphoteric: generally non-irritating; sometimes used in baby shampoos

Chelating Agent (Stability)

• “Kidnaps”/binds metal ions to reduce stability issues (e.g., color/smell/appearance changes).
• Example: EDTA / sodium EDTA

Viscosity Regulator

• Example: sodium chloride (increases/adjusts viscosity)

pH Regulators

• Citric acid (10% solution): lowers pH
• Sodium hydroxide: raises pH

Conditioning / Detangling Agents (Conceptual Role)

• Reduce frizz and help detangle by improving hair fiber behavior (discussed conceptually).

Preservative

• Methylparaben:
  • Extends shelf-life by preventing microbial growth
  • Compatible across the pH range (as described)
  • Non-irritating/non-sensitizing (as described)

Fragrance

• Not used in the demo formulations, but can be added for consumer appeal.

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Ketoconazole Shampoo: Mechanism and Indications (As Stated)

Mechanism of Action

• Ketoconazole acts by inhibiting ergosterol biosynthesis (a key fungal cell membrane component).
• This causes altered membrane permeability, leading to fungal death.

Indications

• Dandruff
• Seborrheic dermatitis
• Additional conditions referenced include psoriasis and pityriasis versicolor (the text is partially garbled, but these indications are clearly referenced).

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Speaker / Sources Featured (As Requested)

• Professor Simone Abreu — pharmacist and instructor presenting the workshop and demonstrations.
• Evandro — participant/assistant (questions/check-ins during the session).
• RDC 528 (Aug 4, 2021) — regulatory citation referenced by the instructor, related to preservatives.