Group 6: La Casa de Medica

 Prado, Beathrese  Seeping, Jeremy

 Royales, Ellie  Valentino, Jamaica

Manufacturing Process of Ferrous Sulfate:

Ferrous Sulfate Capsule contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount
of Ferrous Sulfate (FeSO4 ∙ H2O)

There are several methods through which ferrous sulfate can be produced:
 Being prepared commercially by the action of sulfuric acid on iron. This is the chemical reaction: Fe +
H2SO4 -> FeSO4 + H2 (combining iron with sulfuric acid creates a reaction to form ferrous sulfate and
hydrogen gas)
 It can be generated as a by-product from pickling of steel, since steel pickling refers to a treatment
used to remove impurities, rust, and scale from the surface of a material. During hot working processes,
an oxide layer (referred to as “scale” due to the scaly nature of its appearance) develops on the surface of
the metal. Before most cold rolling processes, previously hot rolled steel goes through a pickling line to
remove the scale from the surface and make it easier to work. To remove this oxide layer a pickle liquor is
used to restore the best corrosion resistant performance, the damaged metal layer must be removed,
exposing a fully alloyed stainless steel surface.
 It is available as a by-product of the manufacture of titanium dioxide, a chemical often used in paint,
sunscreen, and food coloring; coincidentally similar uses to ferrous sulfate.

Procedure:

1. Complex conservation was carried out by preparing 100 ml gelatin and acacia solutions in various
strengths at 40 oC 

2. Ferrous sulfate was dispersed in the acacia solution and stirred it rapidly for 30 min to form the emulsion

3. Add gelatin solution to the emulsion in a dropwise manner

4. The pH of the final mixture was adjusted to 4.5 by pH meter with stirring at 250 r. p. m to induce
coacervation for 1 hour at 40 oC.

5. Cool the product for 3 hours and set aside to form sediment

6.  The resulting sediment was filtered to re-suspend in isopropanol and filtered

7.  Then, the filtrate was dried at room temperature

8. In microencapsulation with aqueous colloidal polymer dispersions, 500 ml of calcium chloride aqueous
solution and 100 ml of sodium alginate aqueous solution were prepared in various strengths

9. Sodium alginate was slowly added to distilled water with constant stirring on magnetic stirrer followed
by mild heating and stirring until the solution became clear.
 10. After this, ferrous sulfate was added in quantities

11. The calcium chloride solution was taken in a beaker and put it on a magnetic stirrer with gentle stirring

12. Then, the beaker was fixed on a stand and dropped the sodium alginate and ferrous sulfate solution into
the calcium chloride solution.

13. The microcapsules particles were formed as drops in calcium chloride solution.

14. The particles were kept in calcium chloride solution for one hour for hardening.

15. After hardening, the particles were sieved through a strainer and washed with distilled water to remove
unencapsulated materials.

16. Finally, the collected microencapsulated particles were dried at 60 °C overnight

Formulation of Ferrous Sulfate:

 Ferrous Sulfate 325 mg

Dried Ferrous Sulfate contain not less than 86.0 percent and not more than 89.0 percent of anhydrous
Ferrous Sulfate (FeSO4)

INGREDIENTS IN EACH

ACTIVE INGREDIENT/ MOIETY

200mg Dried ferrous sulfate USP 325 mg

(65 mg of elemental iron)
INACTIVE INGREDIENT

Gelatin

Glycerin

Polyethylene glycol

Povidone

Propylene Glycol

Water

Sorbitol

Allura red AC (colorant)

LT ORANGE TR.C006 (colorant)

 Note: Excipients used for capsule manufacturing include diluents, fillers and bulking agents. Lubricants
are also used to facilitate filling powder blends into capsule to prevent the adherence of granules and
powders to equipment surfaces and dosator mechanisms.

References (Research)

Manufacturing US20050281732A1 - Method of producing ferrous sulfate heptahydrate. (n.d.). Retrieved

Process October 08, 2020, from https://patents.google.com/patent/US20050281732A1/en

View of PREPARATION OF FERROUS SULFATE MICROCAPSULES AS A SUSTAINED

RELEASE DOSAGE FORMS: International Journal of Applied Pharmaceutics. (n.d.).
Retrieved October 08, 2020, from
https://innovareacademics.in/journals/index.php/ijap/article/view/11251/html

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m33040.html

https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/3179-3180%20Ferrous
%20Sulfate.pdf?fbclid=IwAR3B_N71s7_yZ2B-
5F5dRq9pdRN3_TnNbgRuXrjCqRdgohWMZrsQNBiJDrU
Formulation https://www.drugs.com/pro/ferrous-sulfate-tablets.html

http://dissolutiontech.com/DTresour/201211Articles/DT201211_A06.pdf

https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/3179-3180%20Ferrous
%20Sulfate.pdf?fbclid=IwAR3B_N71s7_yZ2B-
5F5dRq9pdRN3_TnNbgRuXrjCqRdgohWMZrsQNBiJDrU
https://www.capsugel.com/knowledge-center/color-guide-for-food-supplements-hard-
gelatine-capsules