Manufacturing Pharmacy

(Dosage Form to be executed: Cold Cream [Topical Form])

Possible Plant: Oregano (Origanum vulgare)
Objective:
To harness the antimicrobial for treatment for acne and anti-inflammatory of Oregano through
the use of Cold Cream Semi - Solid Dosage Form (Topical).

Rationale:
Oregano is known for its many medicinal properties. From its Anti-Microbial to Anti-
Inflammatory property. Oregano oil often used as ointment. But in this study, the chosen
topical dosage form is cold cream, unlike ointment, the cold cream absorbs into the skin
especially in the face. It also gives moisturizing effect resulting in a cooling sensation (due to
the evaporation of water when applied into the skin, and due to the oily components, it makes
a protectiver layer that traps the moisture giving it cooling effect). And the fact that it
penetrates half-way into the skin, it may also slightly fasten the anti-inflammation effect. It
also treats acne because it has antimicrobial property, they can inhibit various microbial
organisms such as Cutibacterium acnes and Staphylococcus epidermis.
References:
[Link]
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[Link]
ation_of_Cold_Cream_Research_Articles
[Link]
[Link]
regano%20are%20widely%20recognized,antioxidant%2C%20anti%2Dinflammatory%2C%20antid
iabetic%20and%20cancer%20suppressor%20agents.
[Link]

Formulation: [Just refer to the Standard formulation, I guess?]

Oregano Essential Oil………………………………………. 2% w/w (20 g)
Almond Oil (Carrier Oil for dilution) …………………………………….35.5% w/w (355 g)
White wax (for Texture) ………………………………….120 g
Emulsifying wax NF(emulsifier)…………………………………………………… 4% w/w (40 g)
Glycerin USP (Humectant) ……………………………………….23.81 mL
Benzyl Alcohol (Preservatives)………………………………………………… 1% w/w (10 g)

Purified Water ……………………………………………………………….425 mL

Qs. ad…………………………………………………………………… 1000 g

Justification of Formulation:
Mostly of the justification or rationale behind each and every concentration of ingredients in
the formulation is based on the optimal and recommended concentration of USP.
 In terms of the active ingredient, if the formulation used Powdered Extract of Oregano
as its main ingredient, it doesn't pose a use since it is used orally to give its efficacy
since this kind of dosage form is used orally. In this case which is cold cream solution, it
is preferable to use Essential oils in this type of formulation because it can [penetrate]
the skin, can be effective and pose its pharmacological effect. If the Oregano Essential Oil
is being used, it is needed to be diluted because if it directly putted into the solution, it
may cause a negative effect on the skin specially if the skin is sensitive, so it is
 considered to put an approximate amount of 20 g (which Is 2% w/w)
 With regards to the Almond oil,it is included in the formulation with a specific
concentration of 355 g (35.5% w/w) to ensure the fair distribution and equal portions
when it comes for emulsifying oil and water solution in thecream. This is the preferable
carrier oil because unlike any other carrier oils like jojoba oil, this oil exerts many
benefits aside from having an emollient property. [It also enhances Oregano its anti-
inflammatory effect and also it has anti-oxidant {free radicals}]
 In the matter of white wax,with the concentration of 120 g, the rationale behind this
ingredient and concentration, is because this white wax is the standard and
recommended ingredient for making cold cream. Due to its good thickening property,
this is the preferable wax that could come up. [White wax also has Moisturizing property
and can enhance the emulsifying action of the cream]
 With regards of Emulsifying wax NF, this is the optimal agent for emulsion. Due to its
safe, ethical and excellent emulsifying property, this is the chosen emulsifier. [And can
help integrate the oil and water content of the Cold Cream]. In terms of concentration
which is 4% w/w, it is based on achieving an effective emulsification. Typical usage
rates for emulsifying wax range from 2% to 10% of the total formulation weight.
 In terms of Glycerin USP, it is added into formulation because this substance will serve
as a humectant to the product. Ensuring the prolong moisturizing effect of the skin
especially in the face. The chosen concentration of the Glycerin is 3% which is about
23.81 mL, it is adjusted to this volume to ensure the efficacy of the substance and to also
stabilize the formulation.
 With regards to Benzyl Alcohol as preferred preservatives,because of its wide range of
microorganism than can be protected such as bacteria, yeast and molds. It is best for
preservation of cosmetic products especially for cold creams, as for its concentration
which is 10 g it is generally acceptable for cosmetic and pharmaceutical formulations. It
satisfies common industry practices and aligns with USP standard quality requirements.
 In regards of Purified Water,it is preferable as much as possible because on making a
Cold Cream preparation. It is advised that the vehicle and solvent of the said preparation
must have no impurities or microbes instilled on it. It is measuring 425 mL, to sufficient
the quantity to over 1000 g.

Mfg. Procedure:
Manufacturing Procedure for Oregano Cold Cream:
Without Machineries
Phase A: Oil Phase Preparation
- Heat Almond Oil (355 g), White Wax (120 g), and Emulsifying Wax NF (40 g) in a beaker to
around 70°C. Stir continuously to ensure all waxes fully melt and dissolve in the oil.
Phase B: Water Phase Preparation
- In a separate beaker, heat Purified Water (425 mL) ** and Glycerin USP (23.81 mL) to around
70°C. Stir to fully combine.
Emulsification
- Slowly add the heated water phase (Phase B) to the oil phase (Phase A) while stirring
constantly. Use a homogenizer or a high-speed mixer to blend the two phases for a uniform
emulsion.
- Continue stirring for several minutes until the mixture is well emulsified and homogeneous.
Cooling Phase
- Allow the mixture to cool down to around 40°C while stirring gently.
Add Oregano Essential Oil and Preservative
- Once the temperature is around 40°C, add Oregano Essential Oil (20 g) and Benzyl Alcohol
(10 g)
into the mixture. Stir thoroughly to ensure even distribution.
Final Mixing
- Continue stirring the formulation until it reaches room temperature. Ensure that the cream
has a smooth texture and consistent appearance.
Packaging
- Once fully cooled, transfer the cream into sterilized containers. Ensure the packaging is
properly sealed to avoid contamination.
Quality Control
- Conduct stability, pH, and microbial testing to ensure product quality and safety.

This procedure should yield approximately 1000 g of Oregano Cold Cream.

With Machineries:
Phase A: Oil Phase Preparation
 Use a Heated Mixing Vessel to combine Almond Oil (355 g), White Wax (120 g), and
Emulsifying Wax NF (40 g).
 Set the vessel’s temperature to approximately 70°C and use the vessel’s built-in stirrer to
mix until all waxes are fully melted and uniformly mixed with the oil.
Phase B: Water Phase Preparation
 In a separate Heated Mixing Tank, combine Purified Water (425 mL) and Glycerin USP
(23.81 mL).
 Heat this mixture to 70°C while using the tank’s agitator to ensure thorough blending of
the water and glycerin.
Emulsification (Homogenizer)
 Once both phases reach 70°C, slowly pump the heated water phase (Phase B) into the oil
phase (Phase A) using a Peristaltic Pump or Metering Pump for controlled addition.
 Transfer the mixture to a High-Shear Homogenizer and emulsify at high speed until a
uniform and stable emulsion forms. Homogenize for 10-15 minutes to ensure thorough
mixing.
Cooling Phase
 After emulsification, cool the mixture by passing it through a Cooling Jacketed Mixing
Tank or Cooling Tunnel.
 Stir continuously at a moderate speed using a Planetary Mixer or an Agitator as the
temperature drops to around 40°C.
Add Oregano Essential Oil and Preservative
 At 40°C, using the Metering Pump, slowly add Oregano Essential Oil (20 g) and Benzyl
Alcohol (10 g) into the mixture.
 Continue mixing with the Planetary Mixer or Agitator until the additives are uniformly
distributed throughout the cream.
Final Mixing and Quality Check
 Transfer the mixture to a Vacuum Mixer to remove any trapped air and ensure a smooth,
uniform texture.
 Once the cream reaches room temperature, perform quality checks, including pH and
viscosity measurements.
Filling and Packaging
 Use an Automatic Filling Machine to fill the cream into sterilized containers.
  Ensure proper sealing using a Capping Machine to avoid contamination.
Quality Control and Inspection
 Conduct tests for microbial contamination, stability, and consistency using Lab
Equipment like Centrifuges and pH Meters.
 Once approved, label the containers with an Automatic Labeling Machine.

QC:
To ensure the stable and good quality of the Oregano Cold Cream, various Quality Control
Processes should be done. These are the following:
1. Raw Material Testing:
Purity and Identity: Verify the identity and purity of each and every raw material used (e.g.,
essential oils, emulsifying wax, etc.). Ensure they meet the standard concentration of the
formulated cream, and also meet the standard concentration of USP for the legality and safety
of each and every product that is being made.
Storage Conditions: Check that all materials are stored under recommended conditions to
prevent degradation.
2. Formulation Testing:
Mixing Process: Ensure that the mixing process is consistent and thorough. Verify that the
emulsifier, oils, and other components are properly incorporated.
Viscosity: Measure the viscosity of the formulation to ensure it meets the desired consistency.
pH Testing: For topical products, measure the pH to ensure it is within the acceptable range for
skin compatibility.
3. Emulsion Stability Testing:
Physical Stability: Observe the formulation for signs of separation, phase inversion, or changes
in texture over time.
Centrifuge Testing: Use a centrifuge to test the formulation’s stability under accelerated
conditions.
Freeze-Thaw Cycles: Subject the formulation to freeze-thaw cycles to ensure it remains stable
through temperature changes.
4. Microbial Testing:
Preservative Efficacy: Test the formulation for microbial contamination to ensure the
preservative (benzyl alcohol) is effective. This includes testing for bacteria, yeast, and mold.
Challenge Test: Perform a preservative efficacy test to ensure that the preservative system is
adequate to prevent microbial growth.
5. Product Consistency:
Homogeneity: Check the consistency of the product to ensure uniform distribution of
ingredients.
Appearance: Evaluate the color, clarity, and texture to ensure they are consistent with the
intended product specifications.
6. Packaging Integrity:
Seal Integrity: Ensure that the packaging seals properly to prevent contamination.
Compatibility: Test the packaging material for compatibility with the formulation to prevent
interactions that could affect product stability.
7. Stability Testing:
Long-Term Stability: Store samples under various conditions (from high to low temperature
and various environments) and test periodically to assess the formulation’s long-term stability.
Shelf Life: Determine the shelf life of the product based on stability testing results.
8. Documentation and Compliance:
Batch Records: Maintain detailed batch records, including formulations, process parameters,
and QC test results.
Regulatory Compliance: Ensure that the formulation and manufacturing processes comply
with relevant regulations and standards.
9. Consumer Testing:
Sensory Evaluation: Conduct consumer tests to gather feedback on the product’s feel, scent,
and overall acceptability.
Patch Testing: Perform skin patch testing to ensure the product is safe and non-irritating.