Salbutamol Tablets: Uses, Dosage, and Safety

Salbutamol Tablets: Uses, Dosage, and Safety

Salbutamol tablets, also known as albuterol tablets, are a commonly prescribed medication for the management of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). As a bronchodilator, salbutamol tablets help to alleviate symptoms of airway constriction and improve breathing. This comprehensive guide aims to provide a detailed understanding of salbutamol tablets, including their uses, dosage, side effects, and safety considerations. Whether you’re a patient or a healthcare professional, this guide will equip you with the knowledge needed to make informed decisions regarding salbutamol tablet therapy.

Understanding Respiratory Conditions

Asthma: Causes, Symptoms, and Triggers

Chronic Obstructive Pulmonary Disease (COPD): Types and Risk Factors

Role of Bronchodilators in Managing Respiratory Conditions

Introduction to Salbutamol Tablets

What are Salbutamol Tablets?

Mechanism of Action

Available Brands and Forms of Salbutamol Tablets

Medical Uses of Salbutamol Tablets

Treatment and Management of Asthma

Management of Chronic Obstructive Pulmonary Disease (COPD)

Off-Label Uses of Salbutamol Tablets

Dosage and Administration

Recommended Dosage for Different Age Groups

Dosage Forms and Strengths of Salbutamol Tablets

Administration Techniques and Instructions

Monitoring and Adjusting Dosage

Potential Side Effects and Precautions

Common Side Effects of Salbutamol Tablets

Rare but Serious Side Effects

Allergic Reactions and Anaphylaxis

Precautions and Contraindications

Drug Interactions with Salbutamol Tablets

Safety Considerations and Special Populations

Safety Guidelines for Pregnant and Breastfeeding Women

Use of Salbutamol Tablets in Pediatric Patients

Geriatric Considerations and Dosage Adjustments

Managing Salbutamol Tablets in Patients with Comorbidities

Monitoring and Management

Regular Check-ups and Lung Function Tests

Assessing Treatment Response and Adjusting Therapy

Inhaler Technique and Patient Education

Lifestyle Considerations and Self-Care

Asthma Action Plans and Self-Monitoring

Environmental Triggers and Asthma Control

Healthy Lifestyle Habits for Respiratory Health

Frequently Asked Questions about Salbutamol Tablets

Can Salbutamol Tablets Cure Asthma or COPD?

How Long Can Salbutamol Tablets Be Used?

Are Salbutamol Tablets Safe for Long-Term Use?

Can Salbutamol Tablets Be Used as a Rescue Medication?

Emerging Trends and Future Directions

Novel Formulations and Delivery Systems

Personalized Medicine Approaches

Advances in Monitoring and Telemedicine

Conclusion

Salbutamol tablets are an essential medication in the management of respiratory conditions such as asthma and COPD. By understanding their uses, dosage, potential side effects, and safety considerations, patients and healthcare professionals can make informed decisions regarding their therapy. It is crucial to follow the recommended dosage and administration instructions, monitor treatment response, and be aware of potential interactions or precautions. Regular communication with healthcare providers and adherence to an overall management plan can help individuals effectively control their respiratory symptoms and improve their quality of life. With this comprehensive guide, you are equipped with the knowledge needed to navigate the world of salbutamol tablets confidently.

MASTER FORMULA OF SALBUTAMOL TABLET

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 Pharmacist and QC/QA Manager are accountable for the strict adherence to the master formula.

PRODUCT NAME: SALBUTAMOL TABLET, BATCH SIZE:  5.0 LAC

EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION: 

Each Uncoated Tablet contains:

Salbutamol Sulphate B.P. Equivalent to Salbutamol  4 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 27 Stations
Dedusting Machine
Tablet Inspection Machine
Triple Track Blister Machine

RAW MATERIAL:-

 MANUFACTURING SPECIFICATION:

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

The average weight of each Tablet is 220 milligrams.

The weight Variation Limit for the average weight of 20 tablets is + 7.5 %.

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

The hardness of the Tablets varies between 2 – 4 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 25˚C.

Yield:

The theoretical Yield is 5.0 Lacs Tablets.

Expected Practical Yield is 5.0 Lacs + 2% Tablets 

Packing Details:

Use PVC 185 mm transparent and Aluminum foil for blister packing.

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

Put 2 strips each containing 50 tablets in each inner carton.

Put 10 inner cartons in one outer carton.

Seal each outer carton from both ends with cello tape.

Pack 20 outer cartons in specified corrugated box to give a pack size of 20 x 10 x 2 x 50 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 the manner given below using Steam steam-jacketed starch Paste Preparation Tank by operating it.

Dissolve 0.5 kg of Sodium Benzoate in 2 Ltrs of Purified water and stir continuously.

Add 2.0 kg of Starch in 3.0 Ltrs of Purified water and make the slurry stir continuously.

Heat 20 Ltrs of DM water separately.

Dissolve 25g of Erythrocin color in 1Ltr of boiling water and add to the above solution.

To this add the solution of sodium benzoate and starch slurry with constant stirring to get a uniform paste. 

Sifting: Fit Stainless Steel Sieve # 20 on the Sifter. Sift all the ingredients through it and collect them separately in a Stainless Steel Container. 

Blending:  Add the following ingredients to a Roto Cube Blender and start blending for 30 minutes by operating it. Collect the blended powder in Stainless Steel Containers.

20.0 kg of Di-Calcium Phosphate

10.0 kg of Lactose

2.604 kg of Salbutamol Sulphate

42.5 kg of Starch

Wet Granulation: Mix the above-blended ingredients with the Starch paste using the Rapid Mixer Granulator by operating it.  Add starch paste to the blended powder in a manner to achieves proper wetting by following the procedure given below:

Divide the blended powder into two equal parts.

Divide the prepared starch paste into two equal parts.

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

Similarly, mix the next part 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 a Fluidized Bed dryer by operating it  at a temperature of 60˚ – 70˚ C for 30 minutes. Cool the granules to room temperature.

Sifting: Fit Stainless Steel Sieve # 20 on the Sifter-II. Sift the dried 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. 

Lubrication: Lubricate the sifted granules along with the following ingredients in the Roto Cube Blender by operating it. Mix all the ingredients for 15 minutes and collect them in Stainless Steel Container.

0.150 kg of Aerosil

0.500 kg of Magnesium Stearate

6.0 kg of Starch

1.0 kg of Talcum

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 Stainless Steel Container.

Tablet Inspection:  Transfer the compressed tablets to the Tablet Inspection Machine and sort out the defective tablets by operating them and collecting the selected tablets in separate labeled Stainless Steel Containers. 

Loose Packing: Shift the inspected tablets for Loose Packing.

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 it.

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 Pharmacist 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’

OTHER RELATED POST-MASTER FORMULAS OF ALBENDAZOLE TABLETS