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Group 2 1B-PH

Barroga, Beltran, Bocalan, Castro, Cordero

Preparation #20: Terpin Hydrate Oral Solution


DATA SHEET
I. Category
- Medicated Elixir
II. Synonym/s
- Elixir Terpin Hydrate, Terpinol Elixir, Elixir Terpin Hydrate
III. Description of the Final Product
- It is colorless with striations and contains 43% alcohol.
IV. Use/s
- It is used as an expectorant, which assists in thinning the secretions and mucus in the
airway, thereby clearing the pathway for breathing.
V. Formula
Ingredients OA CA

Terpin Hydrate 17 g 0.255 g


Alcohol 430 mL 6.45 mL
Orange Peel Tincture 20 mL 0.3 mL
Benzaldehyde 0.05 mL 0.00075 mL
Glycerin 400 mL 6 mL
Syrup 100 mL 1.5 mL
Purified water 1000 mL 15 mL

VI. Computations
- Terpin Hydrate:
17g / 1000mL (15mL) = 0.255 g
- Alcohol
430 mL / 1000 mL (15mL) = 6.45 mL
- Orange peel tincture
20 mL / 1000 mL (15 mL) = 0.3 mL
- Benzaldehyde
- 0.05 mL / 1000 mL (15mL) = 0.00075 mL
- Glycerin
400 mL / 1000 mL (15 mL) = 6 mL
- Syrup
100 mL / 1000 mL (15mL) = 1.5 mL
- Purified water qs ad 15 mL
VII. Label
- White Label
VIII. Container
- 15 mL narrow-mouth amber bottle
Preparation #20: Terpin Hydrate Oral Solution
POST LAB

1. What is the former official name of the terpin hydrate oral solution?
- Terpin Hydrate Elixir is the former official name.

2. What is the method used in the preparation of terpin hydrate oral solution?
- To prepare terpin hydrate oral solution, agitation without the aid of heat is the method
used. This is also known as simple solution by agitation. It is employed because this oral
solution is an elixir that contains both alcohol and water (hydroalcoholic). Since alcohol is
volatile, heat should be avoided in making elixirs.

3. Compute for the alcoholic strength in %v/v of the prepared elixir?


- Given:
- Alcohol = 6.45 mL
- Total volume of elixir = 15 mL
- Formula:
- % alc strength = [(mL of alcohol)/(Total volume of elixir)] x 100
- Solution:
- % alc strength = [(6.45 mL)/(15)] x 100 = 43% v/v

4. Does the prepared product comply with the terpin hydrate content stated in the USP
monograph?
- The USP monograph for terpin hydrate oral solution states that in 100 mL, it should
contain not less than 1.53 g and not more than 1.87 grams of terpin hydrate. The
prepared product has a total amount of 60 mL, and contains 1.02 g of terpin hydrate.

- To find out the content of the prepared terpin hydrate oral solution, solve:
- 1.02 g terpin hydrate : 60 mL = x g terpin hydrate : 100 mL
- x = 1.7 g terpin hydrate

- Since it has 1.7 g of terpin hydrate, it follows the requirements in its USP monograph,
within the range of 1.53 to 1.87 grams of terpin hydrate.

5. In the preparation of elixirs, talc is most commonly used as a filter aid to remove turbidity.
Explain how this process works.
- The separation of flavoring oils caused by the reduction of alcoholic concentration will
result in a cloudy final mixture of elixirs. Talc acts as a filtering aid in removing the
turbidity in the preparation of elixirs by absorbing the excessive amount of oils.

6. Give the role of the orange peel tincture, benzaldehyde, glycerine, and syrup in the
preparation.
- The orange peel tincture acts as the flavoring agent. The benzaldehyde acts as a
preservative in the preparation. Glycerin and syrup are primarily used as the sweetening
agent in the preparation to aid in its palatability, but also act as thickeners. Glycerin, in
particular, also acts as a solubilizing agent.

7. Explain why the adjunctive solvents glycerine and propylene glycol are commonly
added in manufacturing elixirs.
- The presence of glycerin and propylene glycol in elixirs contributes to the hydroalcoholic
vehicle's solvent action. As a result, they aid in dissolving the solutes present in the elixir.
They also help in improving the preparation's stability. Glycerin is used in elixirs not just
to increase the solubility of medicines, but also to sweeten them.

8. Aside from sucrose, what other materials are used as sweeteners in preparing
elixirs?
- Sorbitol, glycerin, other artificial sweeteners, and saccharin in small amounts may be
used as a substitute for sucrose.
PREP 15 DATA SHEET
I. Category
- Non-medicated elixir
II. Synonym/s
- Iso-Elixir
III. Description of the Final Product
- Clear colorless hydroalcoholic solution
IV. Use/s
- It is used as a vehicle for various medications that require solvent of
different alcohol strength.
V. Formula
Ingredients OA CA

(LAE) (LAE) (LAE)


Compound Orange Spirit 10 mL 0.075 mL
Alcohol 100 mL 0.75 mL
Glycerin 200 mL 1.5 mL
Sucrose 320 g 2.4 g
Purified water, qs ad 1000 mL 7.5 mL

(HAE) (HAE) (HAE)


Compound Orange Spirit 4 mL 0.03 mL
Saccharin 3g 0.023 g
Glycerin 200 mL 1.5 mL
Alcohol, qs ad 1000 mL 7.5 mL

LAE 1000 mL 7.5 mL


HAE 1000 mL 7.5 mL

VI. Computations
LAE
Compound Orange Spirit: 10 mL / 1000 mL (7.5 mL) = 0.075 mL
Alcohol: 100 mL / 1000 mL (7.5 mL) = 0.75 mL
Glycerin: 200 mL / 1000 mL (7.5 mL) = 1.5 mL
Sucrose: 320 g / 1000 mL (7.5 mL) = 2.4 g

HAE
Compound Orange Spirit: 4 mL / 1000 mL (7.5 mL) = 0.03 mL
Saccharin: 3 g / 1000 mL (7.5 mL) = 0.023 g
Glycerin: 200 mL / 1000 mL (7.5 mL) = 1.5 mL

VII. Label
- White Label
VIII. Container
- 15 mL amber bottle
Preparation 15: Post-Lab
1. What is the method used in the preparation of iso-alcoholic elixir?
- The method of preparation used in iso-alcoholic elixir is the admixture of two or more
liquids, particularly the low alcoholic elixir (LAE) and high alcoholic elixir (HAE), which
produces a solution with the right amount of alcohol strength. This method is employed
because iso-alcoholic elixirs contain alcohol, which is volatile in nature, and should not
be heated when making elixirs.

2. Compute for the alcoholic strength (%v/v) of the prepared low alcoholic elixir
- LAE Alcoholic Strength = mL of alcohol/total vol. of LAE x 100
- LAE Alcoholic Strength = 1.5 mL / 15 mL x 100 = 10%

3. What volumes (in mL) of the prepared low and high alcoholic elixirs are to be combined if
a prescription requires 100mL of an alcoholic elixir with 55% v/v alcoholic strength?
- To solve for LAE alcoholic strength,
- LAE Alcoholic Strength = mL of alcohol/total vol. of LAE x 100
- LAE Alcoholic Strength = 100 mL/1000mL x 100 = 10%
- To solve for HAE alcoholic strength,
- First, find the total amount of components. Since saccharin is listed as grams,
use its density to get its value in mL.
- Vol in mL of saccharin = Wt g / Density
= 3 g / 0.828 g/mL
= 3.623 mL
- Next, add this value to the other ingredients, and subtract this from the final volume to
get the amount of alcohol in the HAE.
- Total volume of ingredients = 3.623 mL + 4 mL + 200 mL = 207.623 mL
- Total volume of alcohol = 1000 mL - 207.623 mL = 792.377 mL of alcohol
- Finally, solve for the HAE alcoholic strength.
- HAE Alcoholic Strength = mL of alcohol/total vol. of HAE x 100
- LAE Alcoholic Strength = 792.377 mL/1000 mL x 100 = 79%
- Alligate % of LAE and HAE with a alcoholic strength of 55%
- LAE = 45 parts
- HAE = 24 parts
- Total = 69 parts
HAE = 79% 45 parts

55

LAE = 10% 24 parts

- HAE 69 parts : 100 mL = 45 parts : x mL = 65.22 mL


- LAE 69 parts : 100 mL = 24 parts : x mL = 34.78mL
4.) Why was the low alcoholic elixir allowed to stand for 24 hours?
- This was done to enable the saturation of the hydroalcoholic solvent and to allow the oil
globes to form a mass which will make it easier to remove during filtration.

5. Explain why turbidity occurs when an aqueous solution is added to the alcoholic
solution.
- The turbidity occurs due to the separation of flavoring oils caused by the reduced
alcoholic concentration.

6. A 60-year-old male patient was prescribed with an alcoholic elixir with 40% alcohol
strength for his cough. However, he also orders aspirin for his headache. What will
you tell the patient?
- The patient shall be informed that taking aspirin with the alcoholic elixir has side effects
such as nausea, vomiting, heartburn, ulcers, and stomach ache. It would be better to
substitute either of the two with medicine that has no harmful interactions with the other.
ADD SCREENSHOTS HERE FOR PREP 15 ISO-ALCOHOLIC ELIXIR
INDIVIDUAL DATA SHEETS FOR PREP 16 TERPIN HYDRATE
Leader, Member 2 (Beltran):
Member 1 (Barroga)
Member 3 (Bocalan)
Member 4 (Castro)
Member 5 (Cordero)

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