PPGP-Mfg – OC S4 – PD - FORMULATION

PRODUCT NAME Cetirizine (as Hydrochloride) 5 mg/5 mL Syrup

Batch Size 1,500 L Theoretical Yield 12500 bots x 120 mL

UNIT DOSE AND BATCH FORMULATION

NO. RAW MATERIAL ITEM CODE LABEL CLAIM UNIT OF QUANTITY UNIT OF USE IN THE
NAME (per 5 mL) MEASURE PER BATCH MEASURE FORMULATION
1 Cetirizine Hydrochloride RAS-CET-1 5 mg 0.0625 kg Active Ingredient
2 Methylparaben RES-MEP-1 10 mg 0.125 kg Preservative
(prevent microbial
growth)
3 Propylene Glycol REL-PRG-1 0.25 mL 3.125 L Drug solvent or
solubilizer
4 Sucrose Premium RES-SUP-1 3.25 g 40.625 kg Sweetener
5 Glycerin REL-GLY-1 0.75 mL 9.375 L Sweetener
6 Sodium Citrate RES-SCI-1 5 mg 0.0625 kg Buffering agent
7 Citric Acid RES-CIA-1 2.5 mg 31.25 g Preservative
8 Lemon Flavor REL-LEF-1 0.025 mL 0.3125 L Flavoring agent
9 Purified Water q.s. ad REL-PUW-1 5 mL 62.5 L solvent
Notes:

MW Cetirizine base: 388.89 g/mol

MW Cetirizine HCl: 461.81 g/mol
1,000 mg = 1 g
1,000 g = 1 kg
PPGP-Mfg – OC S4 – PD - FORMULATION

1,000 mL = 1 L

General instructions on the assignment:

1. Use the molecular weights for the computation of adjusted label claim using Cetirizine Hydrochloride.
2. Units of measure are in metric units – mL, mg, g, kg L

QUESTIONS:

1. Compute for the label claim of the product as Cetirizine Hydrochloride (3 pts)
2. Compute for the quantity of each material per batch using the formula:
Quantity per batch = Label claim per mL x Batch size.
PPGP-Mfg – OC S4 – PD - FORMULATION

Round off the computed quantity per batch into a final quantity corresponding to the unit of measure indicated (5 points per item – 45

pts).
3. Indicate the use of each ingredient and the usual or recommended quantity when used in formulations (2 pts each – 18 pts)
4. Aside from the active ingredient, give two (2) other ingredients in the formulation that are considered critical to the performance and
acceptability of the product. Indicate the functions of the other ingredients considered as critical. (4 pts.
a. Ingredient 1 and function – Methylparaben (it is used as a preservative)
b. Ingredient 2 and function - Propylene glycol ( solubilizer )
5. If the quantity of the identified critical ingredients in no. 4 is increased or decreased significantly, what is its impact to the product? (10
pts)
a. Ingredient 1 and impact – - if methylparaben is increased, it may likely cause toxicity if it is decreased, it will have shorter
shelf-life.
PPGP-Mfg – OC S4 – PD - FORMULATION

b. Ingredient 2 and impact - it will have a shorter half-life if the drug increased. If the drug is decreased, it may take a while to
achieve desired drug concentration in the systemic circulation.
c.
6. Give at least two (2) ingredients in the formulation with limit of daily intake and indicate the limit of intake for each? (10pts)
a. Ingredient 1 and limit of daily intake – citirizine Hydrochloride ( limit intake is 10mg)
b. Ingredient 2 and limit of daily intake - methylparaben ( limit of daily intake is 140mg)
7. Give at least two (2) examples of other ingredients used as excipients other than those indicated in the formulation with precautions or
limit of daily intake and maximum quantity of daily intake? Indicate if it is dependent on body weight or other determinant of the limit of
intake. (10 pts)
a. Other material 1 and function – Ethanol→ solvent (adults: 5-8 per kg, children: 3g/kg)
b. Other material 2 and function - Glycerin → solvent (adults: 1-2 g/kg body weight)

Name of Intern/Group No. School University of Perpetual Help System

4 Laguna-Isabela Campus