COLD TABLETS

COLD TABLETS 

Cold and cough medicines can help relieve symptoms of a common cold. The symptoms of a cold can include a sore throat, stuffy or runny nose, sneezing, and coughing.

You don’t usually need to treat a cold or the cough that it causes. You can’t cure a cold, and antibiotics won’t help you get better. But sometimes the symptoms can keep you awake or cause a lot of discomfort. In that case, cold and cough medicines can sometimes be helpful.

As the seasons change, so does the risk of catching a common cold. Cold tablets, also known as cold and flu tablets, are popular over-the-counter remedies for alleviating the symptoms associated with the common cold. This comprehensive blog post serves as the ultimate guide to cold tablets, providing valuable information about their purpose, ingredients, effectiveness, and safe usage. Whether you’re seeking relief or looking to understand these medications better, this guide will equip you with the knowledge you need.

Conclusion (Word Count: 400) Cold tablets are a convenient and accessible solution for alleviating the discomfort caused by the common cold. By understanding their purpose, ingredients, effectiveness, and safe usage, you can make informed decisions when selecting and using these medications. Remember to consult a healthcare professional if you have any concerns or questions regarding cold tablets, and always follow the recommended dosage and usage guidelines. With this ultimate guide, you can navigate the world of cold tablets confidently and find relief during the cold and flu season.

What are the different types of cold and cough medicines?

There are lots of different cold and cough medicines, and they do different things:

  • Nasal decongestants – unclog a stuffy nose
  • Cough suppressants – quiet a cough
  • Expectorants – loosen mucus in your lungs so you can cough it up
  • Antihistamines – stop runny noses and sneezing
  • Pain relievers – ease fever, headaches, and minor aches and pains

What do I need to know about taking cold and cough medicines?

Before taking these medicines, read the labels and follow the instructions carefully. Many cold and cough medicines contain the same active ingredients. For example, some of them include pain relievers. If you are taking these medicines and are also taking a separate pain reliever, you could be getting a dangerous amount of the pain reliever.

Do not give cold or cough medicines to children under two, and don’t give aspirin to children.

What else can I do to feel better about a cold or cough?

If you decide that you don’t want to take cold and cough medicines, there are other ways to feel better:

  • Drink lots of fluids
  • Get plenty of rest
  • Use a cool mist humidifier
  • Use saline nose drops or sprays
  • Use nasal suctioning with a bulb syringe, which can be very helpful in children under a year old.

As the seasons change, so does the risk of catching a common cold. Cold tablets, also known as cold and flu tablets are a popular over-the-counter remedy for alleviating the symptoms associated with the common cold. This comprehensive blog post serves as the ultimate guide to cold tablets, providing valuable information about their purpose, ingredients, effectiveness, and safe usage. Whether you’re seeking relief or looking to understand these medications better, this guide will equip you with the knowledge you need.

Understanding the Common Cold

Definition and Causes of the Common Cold

Symptoms and Duration of the Common Cold

Transmission and Prevention of the Common Cold

Purpose and Benefits of Cold Tablets

Introduction to Cold Tablets

Symptom Relief is Provided by Cold Tablets

Advantages of Cold Tablets over Other Remedies

When to Consider Cold Tablets for Cold Relief

Key Ingredients in Cold Tablets

Analgesics and Pain Relievers

Decongestants

Antihistamines

Expectorants

Cough Suppressants

Combination Ingredients

Understanding Active Ingredients and Their Functions

Effectiveness and Efficacy of Cold Tablets

Evidence-Based Research on Cold Tablets

Assessing the Effectiveness of Cold Tablets

Factors Influencing the Efficacy of Cold Tablets

Choosing the Right Cold Tablets

Understanding Your Symptoms and Needs

Considerations for Specific Populations (e.g., Children, Pregnant Women)

Reading Labels and Understanding Dosage

Consulting a Healthcare Professional

Safe and Proper Usage of Cold Tablets

Following the Recommended Dosage

Understanding Potential Side Effects and Interactions

Precautions and Contraindications

Avoiding Medication Overuse and Dependence

Storage and Disposal of Cold Tablets

Combining Cold Tablets with Other Remedies

Lifestyle Changes for Cold Relief

Home Remedies and Natural Supplements

Integrating Cold Tablets with Other Medications

Frequently Asked Questions about Cold Tablets

Can Cold Tablets Cure a Cold?

Can I Take Cold Tablets with Other Medications?

How Long Can I Use Cold Tablets?

Can I Take Cold Tablets if I Have Certain Medical Conditions?

Myth-Busting and Misconceptions about Cold Tablets

Cold Tablets and Antibiotics

Cold Tablets and Immunity Boosting

Cold Tablets and Drowsiness

Cold Tablets for Children and Special Populations

Safety Considerations for Children

Cold Tablets for Pregnant Women and Breastfeeding Mothers

Elderly Population and Cold Tablets

Conclusion

Cold tablets are a convenient and accessible solution for alleviating the discomfort caused by the common cold. By understanding their purpose, ingredients, effectiveness, and safe usage, you can make informed decisions when selecting and using these medications. Remember to consult a healthcare professional if you have any concerns or questions regarding cold tablets, and always follow the recommended dosage and usage guidelines. With this ultimate guide, you can navigate the world of cold tablets confidently and find relief during the cold and flu season.

MASTER FORMULA OF COLD TABLETS

PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, and packing details of the dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of the Manufacturing Chemist to follow and adhere to this SOP. The Production, QC/QA Managers are accountable for the strict adherence to the master formula.

PRODUCT NAME: COLD TABLET, BATCH SIZE:  10.0 LAC

EXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each uncoated Tablet contains:

Acetaminophen  I.P. 500 mg

Pseudoephedrine Hydrochloride  I.P. 30 mg

Cetirizine Dihydrochloride B.P. 10 mg

 

EQUIPMENT TO BE USED:

Steam Jacketed Starch Paste Preparation Tank
Sifter Machine
Roto Cube Blender
Rapid Mixer Granulator
Multi Mill
Fluidized Bed Drier
Oscillating Granulator
Sifter Machine 
Roto Cube Blender
Tablet Compression Machine
Dedusting Machine
Tablet Inspection Machine
Triple Track Blister Machine

RAW MATERIAL:-

INGREDIENTS Total Quantity Used
Aerosil 1.500 kg.
Cetrizine Di Hydrochloride 10.000 kg
DI calcium Phosphate 20.000 kg
Lactose 20.000 kg
Micro Crystalline Cellulose Phosphate 21.000 kg
Magnesium Stearate 4.000 kg
Paracetamol 500.000 kg
Pseudoephedrine Hydrochloride 30.000 kg
Sodium Benzoate 2.000 kg
Starch 110.00 kg
Starch 20.000 kg
Starch 20.000 kg
Talcum 6.000 kg
Sodium Starch Glycolate 1.66 kg

 PACKING MATERIAL:- 

NAME OF THE MATERIAL TOTAL QUANTITY USED
220 MM RED (PVC) 130.000 KGS
ADHESIVE TAPE ROLL BROWN 2.000 NOS
ALUMINIUM FOIL 3 – TRACK 30.000 KGS
CELLO TAPE 6.000 NOS
UNIT CARTON  – 20 X 10 5002.00 NOS
CORRUGATED BOX 83.000 NOS

MANUFACTURING SPECIFICATION:

The moisture content of powder should be less than 2.0 %.

The average weight of each Tablet is 750 milligrams.

The Weight Variation Limit for the average weight of 20 tablets is + 5.0 %.

The friability limit for 20 Tablets is not more than 1.0 %.

The hardness of the Tablets varies between 4 – 5 kg/cm2.

Disintegration time for each Tablet is not more than 15 minutes.

Mix the batch, compress and de-dust the tablets, and also perform the primary packing of Tablets at a temperature not more than 250 C.

Yield:

The theoretical Yield is 10.0 Lac Tablets.

Expected Practical Yield is 10.0 Lac + 2% Tablets.·       

Packing Details:

Use PVC Red 220 mm and Aluminium foil for blister packing.

Blister Pack the inspected and De-dusted tablets by using the Triple Track Blister Packing Machine.

Put 20 strips each containing 10 tablets in each carton.

Seal each carton from both ends with cello tape.

Pack the 60 cartons in specified corrugated box N-34 to give a pack size of 60 x 20 x 10 tablets.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Preparation of Starch Paste:

Prepare the starch paste in two lots.

Prepare the starch paste in the manner given below using Steam steam-jacketed starch Paste Preparation Tank by operating it.

Dissolve 2.0 kgs of Sodium Benzoate in 4.0 Ltrs of Purified water and stir continuously.

Add 10.0 kgs of Starch in 10 Ltrs Purified water and stir continuously to make a smooth slurry.

To 85 Ltrs of boiling water add the solution of sodium benzoate and starch slurry with constant stirring to get a uniform paste

Repeat the same process for the next lot.

Sifting:

Fit Stainless Steel Sieve # 40 on the Sifter. Sift all the ingredients through it and collect them separately in a Stainless Steel Container.

Blending:

Blend the following ingredients in a Roto Cube Blender by operating it for 30 minutes and collect in Stainless Steel Containers.

110.0 kgs of Starch

20.0 kgs of Dicalcium Phosphate

20.0 kgs of Lactose

10.0 kgs of Cetirizine Di Hydrochloride

21.0 kgs of M.C.C.P.

500 kgs of Paracetamol

30.0 kgs of Pseudoephedrine Hydrochloride

Repeat the same process for the next lot

Wet Granulation:

Mix the Above blended ingredients with the Starch paste using the Rapid Mixer Granulator operating it. Add starch paste in such a manner by following the procedure given below to achieve proper wetting.

Divide the blended powder into twenty equal parts.

Divide the total prepared starch paste into twenty equal parts.

Mix one part of the blended powder and starch paste in the Rapid Mixer Granulator.

Similarly, mix the rest of the parts in the same manner.

Wet Screening:

Pass the wet dough through a Multi Mill by operating it to convert the moist mass into coarse, granular aggregates.

Drying:

Dry the granules in the Fluidized Bed Drier by operating it at a temperature of 60˚to70˚C for 30 minutes. Cool the granules to room temperature.

Sifting:

Fit Stainless Steel Sieve # 14 on the Sifter. Sift all the granules through it and collect them in a Stainless Steel Container. Break the oversized granules left over the mesh in the Oscillating Granulator by operating it and resifting them.

Check the total weight of dried granules. Determine the loss on drying and the percentage yield of dried granules. Divide the dried granules into two equal lots.

Lubrication:

Lubricate one lot of the sifted granules along with the following ingredients in the Roto Cube Blender by operating it for 15 minutes and collect in Stainless Steel Containers. 

0.75 kgs of Aerosil

2.0 kgs of Magnesium Stearate

10.0 kgs of Starch

3.0 kgs of Talcum

Repeat the same process for the next lot with the same quantity mentioned above.

Send the granules for bulk testing to the Quality Control Department for assay of Active Ingredients.

Compression:

Shift all the granules for compression to Tablet Compression Machine 27 Stations by operating it and collecting the compressed tablets in a Stainless Steel Container.

Tablet Inspection:

Transfer all the tablets to the Tablet inspection machine and sort out the defective tablets by operating it and collecting the selected tablets in a Stainless Steel Container.

Blister Packing:

Shift the inspected tablets to the blister section and blister pack them using the Triple Track Blister Packing Machine by operating it.

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purposes are all approved materials and have ‘Released’ labels fixed on them.

All weighed Raw materials should be counter-checked by the Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of the Production and QC/QA Manager.

Physical characteristics of Raw materials like color, odor, and consistency are checked before compounding.

Humidity and temperature should be maintained during the compression of thermolabile products.

A sample of dried granules should be sent to the Quality Control Department for the determination of Moisture content.

The total weight of blended powder should be checked in the presence of the Manufacturing Chemist and recorded the same in the Batch Manufacturing Record.

Bulk samples should be sent for analysis to the Quality Control Department before starting the compression of tablets.

Weight Variation: I) Intermittently weight variation of compressed tablets should be checked at 30 minutes intervals by the Assistant Manufacturing Chemist and a record for the same should be kept in the Batch Manufacturing Record

Out-of-limit tablets should be checked by the Weight Variation Method.

Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per below by IP/BP/USP:

Take the weight of individual tablets and check if all the tablets are lying within the limits.

Select the tablets only if no more than two tablets are out of the percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

Adjust the desired weight of the tablets in the Compression Machine by moving the weight adjustment cam clockwise or anticlockwise accordingly as per the Standard Operating Procedure of the Compression Machine.

Re-check the weight of tablets for further adjustment, if any.

The thickness of Tablets: The thickness of the tablets should be determined using the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets: The equipment used is the ‘Monsanto’ type hardness tester. The hardness of the compressed tablets should be checked at regular intervals to determine the need for pressure adjustments on the tableting machine.

The hardness of tablets varies between 2-4 Kg/cm2.

Friability:

Roche Friabilator is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping.

Adjust the instrument to 25 RPM before adding the tablets.

Weigh 20 Tablets on a calibrated balance. Transfer the tablets to the plastic chamber. Close the drum tightly.

Switch on the apparatus. Operate the Friabilator for 100 revolutions.

De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand wear.

Take 10 tablets to check the friability, when the average weight of the tablet is 1g or more than 1g.

 Friability Limit  = Less than 1.0%

Disintegration Test:

Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular intervals of 1 hour by using the Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the tablets in each of the 6 tubes along with a plastic disc over the tablets.

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C throughout the test by suitably setting the thermostat.

Introduce a tube assembly unit into a glass beaker in such a way that the wire mesh at the base of each tube is at least 2.5cm below the surface of the liquid when the basket is at its highest position.

Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of the tube, stop the stopwatch. Note the time taken for the disintegration of the tablets and record the same in the Batch Manufacturing Record.

If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.

Inspection and sorting of rejected tablets should be done.

The strips and cartons should be checked thoroughly for proper batch coding.

The Manufacturing Chemist and Production should randomly check that the correct no. of strips are being packed in each carton and also the number of cartons in each shipper is the same as that shown in the proof.

Intimation should be sent to the Quality Control Department for finished product sampling and testing.

After the completion of labeling and packaging, the coded cartons should be accounted for, and rejected printed material should be destroyed in the presence of the QC/QA Manager. Fill out the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensured that filling or packaging equipment has been properly cleaned after the completion of the batch.

Filling or packaging of the next product should not commence until the IPQA has given the ‘Line Clearance’

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References: MedlinePlus