Formulation of Potassium Chloride Syrup (Sugar Free) 20 mEq K per 5 ml

Potassium Chloride Syrup Sugar Free is not available in Pakistani Market. K-LYTE syrup is a Pakistani brand of 13.33 m Eq/5ml Potassium supplement syrup, which is not available. People mostly suffering from Hypokalemic periodic parlysis needs daily supply of this syrup for their normal body function. It is fast release potassium suppliment. Aga Khan pharmacy and Kausar Medicos are the two major pharmacies who are supplying this syrup for 7 days shelf life. One day booking next day delivery basis. 

I request Prime Minister of Pakistan, Health Minister to made available this product for us, we and our families suffers a lot to make available this syrup for us.

I was working on formulation of Sugar Free Potassium Chloride Syrup after publishing powder formulation of this drug. Now I am reached on a formulation for this syrup available in literature, I just arranged headings and made some comments and suggestions. 

K-LYTE Syrup Sugar Free

Commercial Production of Potassium Liquid

• Batch Size:   1000 litre
• Practical Yield: 4900 bottles of 200 ml
• Usual Packing :  200 ml amber bottle

Labelled Formula:

• Each 5 ml  contain
• Potassium Chloride  1.33 g
• Potassium Gluconate 0.50 g
• Which will provide 20 mEq of Potassium

Formulation:

Potassium source:

• Potassium chlorode                              93.11 kg
• Potassium gluconate                             35.11 kg

Inactive Ingredients:

• Citric acid                                            23.00 kg
• Glycerine                                            100.00 kg

Colour:

• Caramel colour                                       1.33 kg
• Amaranth colour                                     0.03 kg
• SSY colour                                             0.01 kg

Sweetner:

• Saccharin insoluble                                 2.50 kg
• Orange Flavour:                                      6.00 kg
• Raspberry sweet flavour                         2.00 kg

Preservative:  

• Bronidiol                                                 1.00 kg
• Sorbic acid                                               0.50 kg

Mineral Water: used as a solvent

Discussion on Formulation:

Source of Potasium:

• Potassium Chloride is normally used as a source of potassium because it is very cheap.  Other potassium supplying material can also be used in singly or in combination. e.g.  Potassium gluconate, Potassium citrate, Potassium bicarbonate. Milli equivalents content of K per gram of these material are given below.

• Potassium chloride                13.33 mEq/g
• Potassium citrate                     9.8   mEq/g
• Potassium bicarbonate           10.0   mEq/g
• Potassium gluconate                 4.3   mEq/g

Preservatives:

• Instead of Bronidiol , you can choose Methyle paraben and proplyle paraben. The Maximum limits of these preservative are as under

• Bronidiol                            0.01%  w/v
• Sodium methyleparaben     0.10 %  w/v
• Sodium proplyparaben       0.012%  w/v
• 
  
• Instead of Sorbic acid , sodium metabisulphate can be used.

Sweetner:

• Instead of Sacchrin insoluble, Sodium saccharin, sorbitol or aspartame can be used.

Colours and Flavours:

• The colour depends upon the flavour used, and their quantities depends upon the brand used.

Manufacturing Process:

• Heat 450 ml of mineral water in a stainless steel pan to 80 degree centrigrade.
• Now add and dissolve Potassium gluconate, Potassium chloride, Bronidol and Citric acid one by one.
• Then add glycerind and mix well.
• Now in another stainless steel pan boil  150 litre  mineral water, add sacchrine and Sorbic acid, mix and dissolve well. Then add this nixture to above mixture while hot.
• Maintain temperature of this solution to 80-90 degree centrigarde for 15 minutes, then cool.
• Now dissolve colour in boiled cold water, then pour in the prepared solution.
• Similarly add flavours and make up the volume to 1000 litre.

• Check pH:  5  -  7.5

• Pass through Sparkler filter press, using Hy-flo supercel as filtration aid.

http://www.sparklerfilterpresses.com/

http://www.sigmaaldrich.com/catalog/product/sial/56678?lang=en&region=PK

• Keep the prepared solution in a pan with lid on till ready for packing in 200 ml amber colour bottles. 

Warning:

1. This is a Medicine, used only for patients on doctor's advise.  Dose and duration depends upon doctor's prescription.

2. Check for validity of the above mentioned formulation, this is available in literature, but I think their is some mistake in 5ml dose gives 20 mEq and batch size calculations. But the process is authentic and material used.  Experts in this field can easily detect, I am not correcting it, because pratical yield 1000 litre should contains 266 kg of KCl for 5 ml dose....................,.

Formulation of Potassium Chloride 20 mEq K Powder for Oral Solution

Nowadays quick release Potassium Syrup K-Lyte is not available in Pakistan, peoples like me suffering from hypokalemic periodic paralysis suffers a lot. We need twice or trice 2 teaspoon daily to move and work.



 I and many patients living in Karachi are going to Aga Khan Hospital pharmacy or Kausar Medicos to buy this medicine. Aga Khan only provides Syrup for 7 days, 1 day booking next day delivery basis. Patients and their family members travel 4 days a week to book and get medicine.  I  talked to Aga Khan pharmacy to give this syrup atleast for 1 month, but they replied that we can not prepare this syrup more than 15 days expiry.  I asked them to develop a powder form or increase the shelf life of syrup  by adding some suitable preservative. They replied that at present we have no such plan or formulation. Keeping this in my mind , as a Food Technologist and Applied Chemist, I started working on 20 mEq Potassium powder for oral solution, Alhamdo lillah I finally achieved the goal.  Here is my formulation based on Potassium Chloride giving 20 mEq of Potassium in pleasant orange flavored powder when dissolved in water.

Commercial Formulation and Manufacturing Process (simplified):

Formulation For 100 kg Batch:

Potassium Chloride , powder                              86.000 kg
Malic Acid anhydrous, powder                           12.200 kg
Food Colour SSY (E-110)                                   00.050  kg
Orange Flavour, powder                                       1.000   kg
Aspartame, artificial sweetner, powder                0.250 kg
Amorphous Silicone Dioxide, powder                  0.500 kg

Flavour , Colour , Artificial sweetener's quantities are adjustable according to brand and quality used.
Potassium Chloride quantity will remains same. Malic acid is adjustable to made full 100 kg accordingly.


Manufacturing Process:
Mix together amorphous silicone dioxide and flavour powder, then add colour and 2 kg potassium chloride and mix well. Add malic acid and potassium chloride in portion while mixing till all malic acid and Potassium Chloride are consumed.

Packing:
 1.75 g Sachet
This Sachet will give 20 mEq of K (Potassium)

How Consume:  Dissolve 1 Sachet in 1/2 to 3/4 glass of water.

Warning: This product is only for patients suffering from Potassium depletion, not for general use. Dose and duration depends upon doctor's prescription.