SOP for Preparation of Iron Syrup: 1243785

Introduction 

The syrup is a thick highly dense liquid generally made in the presence of sugar and water, the preparation of syrup is carried out with or without the presence of flavored additives. The liquid nature of the syrup assists in the faster absorption of the medication in comparison to the tablets; therefore it is more preferred over a tablet in some cases, where quick response is required, (Drumond et al., 2017). The present work was carried out for the preparation of Iron syrup. The iron syrup is highly applicable to the disorders related to the lack of iron in the body.

Aim

The lab experiment was conducted for the preparation of iron syrup using ferrous sulfate.

Objective

  1. Ferrous sulfate of 99.7 % purity was used for the preparation of iron syrup.
  2. Analysis of various aspect involved in the preparation of  iron syrup was carried out.

Materials and Method

The materials that were used for the preparation of iron syrup were:

Chemical:

FeSO4, Citric acid, Ascorbic acid, Liquid Glucose, Sucrose Syrup (Conc 67% w/v), Methyl Paraben, Propyl Paraben, Sodium saccharin, Glycerin, Raspberry Flavor, Raspberry Red Color and distilled water.

The apparatus used for the study:

Beaker, Filter paper, Stirrer, Measuring cylinder, Balance, Pipette, Bottle with lid, Funnel, Glass rod, labels.

 

 

 

Experiments/ Methodology applied for the preparation of iron syrup

Table 1 Formula for 25 ml syrup

Name of the ingredientCalculated weightActual weight (g)
FeSO41.0  gm1.0338
Citric acid100  mg0.1024
Ascorbic acid50  mg0.1185
Liquid Glucose 2.5 ml2.5
Sucrose Syrup5 ml5
Methyl Paraben45 mg0.0045
Propyl Paraben5 mg0.0054
Sodium saccharin2.5 mg0.0040
Glycerin1 ml1 ml
Raspberry Flavor q.s3 drop
Raspberry Red Colorq.s3 Drop
Distilled Waterq.s  to 25 ml  
  1. The weight of the solid was carried out using weighing balance and for liquid measurement measuring cylinder and pipette was used.
  2. The preparation of iron syrup was carried out in an glass beaker, initially 1.0338 g ferrous sulfate was introduced in a clean beaker, subsequently distilled water (DW) was added and the mixing was carried out using a glass rod.  
  3. To the above mixture 0.1024 g citric acid and 0.1185 g ascorbic acid was added and subsequently mixed with the help of glass rod, the final solution was stored.
  4. In an separate beaker 0.0045 g methyl paraben, 0.0054 g propyl paraben and 0.0040 g sodium saccharin was added along with 5 ml of sucrose syrup, subsequently liquid glucose 2.5 mL and glycerin 1 ml was added and stirred with the help of glass rod.  
  5. The mixture prepared in the step four was added to the mixture in step three and vigorous stirring was carried out using glass rod until the homogenous solution was not obtained.
  6. To the homogenous solution 3 drops each of Raspberry flavor and color was added and stirred.
  7. The mixture was filtered to remove any particulate matter in the homogenous mixture in an a measuring cylinder, and the final volume 25 ml mas make up using DW.
  8. The filtered solution was transferred in a bottle and labeled accordingly.   

 Calculations

An assumption was made that the initial calculation given for the ferrous sulfate was for the solid with 100 % purity. Therefor for the solid with 99.7 % purity, the amount of ferrous sulfate required for will be:

  • Total amount of 100 % pure ferrous sulfate required for the preparation of 25 ml solution is = 1g
  • In case of the solid with 99.7 % purity x g of ferrous sulfate is required

x = 1.003 g

1.003 g of ferrous sulfate was required for the preparation of 25 ml iron syrup

For the preparation of 25 L (25000 ml)syrup

25000 ml will require =   

                                     =1003 g

Assumption was made regarding the purity of other materials and it was assumed that the purity of the material remained the same therefore the amount of material required for 25 L.

For citric acid, the earlier requirement was of 100 mg for 25 ml, for the preparation of 25 L  

=100 g

For Ascorbic acid, the earlier requirement was of 50 mg for 25 ml, for the preparation of 25 L  

=50 g

For liquid glucose , the earlier requirement was of 2.5 ml for 25 ml, for the preparation of 25 L  

=2500 ml

For sucrose syrup , the earlier requirement was of 5 ml for 25 ml, for the preparation of 25 L  

= 5000 ml

For Methyl parabon , the earlier requirement was of 45 mg for 25 ml, for the preparation of 25 L

= 45 g

For propyl parabon , the earlier requirement was of 5 mg for 25 ml, for the preparation of 25 L

= 5 g

 For sodium saccharin, the earlier requirement was of 2.5 mg for 25 ml, for the preparation of 25 L

=2.5 g

 For glycerin, the earlier requirement was of 1 ml for 25 ml, for the preparation of 25 L

= 1000 ml

For distilled water, the earlier requirement was of 1 ml for 25 ml, for the preparation of 25 L

= 25000 ml

Discussions 

The preparation carried out in the lab was for small scale preparation of the volume of 25 ml, and it was observed that the weighing of the sample should have been carried out with more precision as errors were observed when the actual weight was compared with the actual weight taken. The study conducted by (Poskurica et al., 2015), reported the application of iron-containing syrup for an increase in hemoglobin concentration. The study conducted by (Nisar & Michael, 2016), reported that the use of iron syrup at the time of pregnancy helped in a deduction in a number of neonatal death.

 

Conclusion

The present study was carried out for the preparation of iron syrup using ferrous sulfate The liquid nature of the syrup assists in the faster absorption of the medication in comparison to the tablets; therefore it is more preferred over a tablet in some cases, where quick response is required. The model calculation was carried out for the preparation of iron syrup with 99.7 % purity. Scale-up calculations for 25 l product was also carried out on the basis of the data available for the preparation of 25 ml iron syrup.

 Label

Name of preparation (quantity in ml) = Iron syrup (25 ml)

Drug content:

Name of the ingredientActual weight (g)
FeSO41.0338
Citric acid0.1024
Ascorbic acid0.1185
Liquid Glucose 2.5
Sucrose Syrup5
Methyl Paraben0.0045
Propyl Paraben0.0054
Sodium saccharin0.0040
Glycerin1 ml
Raspberry Flavor 3 drop
Raspberry Red Color3 Drop
Distilled Water 

Use of preparation= Mixing

Dosage: “as directed by physician”

Direction: Based on the SOP

Auxiliary label: Kindly consult medical professionals prior to the use of syrup

Storage condition: Room temperature in dark

Mfg date:       4/5/2020                                        Exp date:3/4/2022

Batch No.2123424321

Manufactured by: Lab

Reference  

Drumond, N., van Riet-Nales, D.A., Karapinar-Çarkit, F. & Stegemann, S., 2017. Patients’ appropriateness, acceptability, usability and preferences for pharmaceutical preparations: results from a literature review on clinical evidence. International journal of pharmaceutics , 521(1-2), pp.294-305.

Nisar, Y.B. & Michael, J.D., 2016. Iron/folic acid supplementation during pregnancy prevents neonatal and under-five mortality in Pakistan: propensity score matched sample from two Pakistan Demographic and Health Surveys. Global health action, 9(1), p.29621.

Poskurica, M., Petrović, & Poskurica, M., 2015. Administration of iron in renal anemia. Vojnosanitetski pregled , 72(4), pp.361-67.