[-ahoratorv Guide for Mianufacture of Drugs, Cosnnetics and Veterinary lVledicine

Group no
Company Name
Nlame:

Product Name S[JtF AZf,hIE * SU FAftfiERAZIhIE _ SULFARf,ET NE

OR sLispE t0N
ShelfLife.3years
l\flanurfacturing OrcJer No. . Eatch Size: 100 m
Finishing Order No Date of.hrlanufacture
Batch l\umber" Expiry Date

0bjectives:
,l
To manufacture Sulfadiazine Sulfarnerazine - Sulfamethazine Oral
Suspension by Dispersion method, with the use eif Homogenizen, in compliance
to cGlVlP standards.
To tabel the finished product according to the FDA requirements.

[\llater"lais:
Evaporating dishes l\llettler PE Analytical Balance
Watch glasses Colloid t\/ill / Homogenizer
Spatulas (porcelain and metal) Eleetrie Stove / Hot Plate
Erlenmeyer flask, 2S0 mL, S00 mL
Beaken, 250 n'rl Graduated cylinder, 50 rnL
lVlortar and Festle 8R krottle, flint, 120 mL
Test tubes Labeling ancl Packing materials

Fornnula for 100 nnL;

0.83 g
Simple Syrup 20.00 mL
Serdiunr citrate 0.67 g
Sulfadiazine, USP 2.12 g
Sulfamerazine, USP 2.12 g
Sulfamethazine, USP ------ 2."t2 g
fillethyl parabens 0.17 g
Banana flavor qs
Furified water, qs ael -------------- 1 00 mL

CEU Schooi of Phanmacy '1,9[Page

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Laboratory Guide for hlanufacture of Drugs, Cosmetics and Veterinary tr/ledicine

A. Elsmensi Proaedures
1. Weigh the fclllowing: 20 grams suerose, veegum, Dispensed by: _
sulfadiazine, sulfamethazine, and sulfamerazine. Checked by

lVleasure the following: 20 mL purified water,

Banana flavor and 60 mL purified water.

B-QqtEpou nd i n g Pnoeed u res :

1. Prepare Simple Syrup by dissolving 20 grams of Done by:

sucrose in 20 ml of boilinE water in a hreaker" Checked by: .--
Set aside to cool.

2. ln the beaker containing simple syrup, suspend Done by

veegum powder. Checked by:

3. Stir in sodium citrate to this miNture

--_
Done by:
lncorporate banana flavor. ehecked by
r{. Fre-nnirr the dry sulfa powclers in a mortar. Done by:
Gradually adel the sulfa clrugs to the gum-syrup Checked by._--
rnixture.
5. Triturate until the suspension is homogenously blended Done by
and free of lumps. Checked by: _
6. ln a test tube, elissolve methyl parabens in 5 mL Done by: _
purified water. lncorporate this to the bulk procluct" Checked by:
--
7. Pass the bulk suspension throurgh the homogenizer Done by
several times, until a hornogenous, creamy, viscous Checked by: _
suspension is produced.

-e . Paqkqqing Frqqed,urqq;
8. Fill the product into a 120 mL wide-mouthed Eoston- Filled by:
round bottle. Checked by:----
---.-
9 Affix the label and place finished Brocluet Finished by: _
in a unit box. Checked by:
---

CEU School of Pt"larmacy 20 lPaEe

 l-abonatory Guide for Manufacture of Drugs, Cosmetics and Veterinary l\fledicine

$amp!_e_L=ahel;

100 nnl Lot no.:

Each teaspoon eontains Date NIf'd:
Expiry Date
Sulfadiazine--- SULFADIAZIhJE
Sulfarnerazine---- SULI.-AIVIERAZINE
SulfamethaztRe ---- SULFAIVIETHAZINJE

Brand Name
Dose: Rx
As Direeted by the Antibacterial
Physician.
Storage:
Caution: Keep tightly closed in a
Food, Drugs, Cosmetics, hflanufactured by: cool, dry place.
and Devices Law prohibit
dispensing vvithout a Company l\ame SHAKE WELL BEFORE
prescription. eEU fr/endiola, fillanila USING

CEU $choolof Pharmacy 2tlPage

l-aboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Meciicine

Finishing CIrder n0.4.

S T-! LFADIAZI H\3 E * RAZI hJ E * S U LFAIUI ETHAZI

S U LFAfrfd E NH
ORAL SUSPEIdSIOIV
tot Nunmber:

Yr and Section Group no

Name

Company Name Date of IVlanufacture

l. Job Rotations

Group hflembers Job Rotation Scores

1

2
3
4

ll. Computations of Labeled e laim of the Aetive/s

lll. Produet Evaluation:

Actual Resu of the Evalu

eolor:
Odor.
Taste
Produet Appearance
Container Finish:
Unit Label and Eox Frint

CEtJ School of Fharrnacy 22lFage

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I
'It

Laboratory Guide for lVianufacture of Drugs. Cosnretrcs and Veterinary lVledicine

lv. Photographs of the finishecl pnoduet, Label and unit box.

of Fharmacy
23lFage
 [-aboratory Guide for lVlanufacture of Drugs, Cosrneties and Veterinary lVledicine

V. QUESTIONS:

1 What is the purpose of passing the procluct through a homogenizen? What other
equipnnent can be used in'place of a homogenizer to achieve the same effect on
the product?

2. Sketch and illustrate the rotor-stator mechanism inside the homogenizer.

i.

3" [-ist clovvn at least five (5) elinical applieations of sulfa drugs. Enumerate"
Explain the ar:lverse reactions etf surlfadiazine, sulfarnethazine and sulfamerazine.

CEU School of Pharmacy

24lflaEe