Mebendazole Tablets: Uses, Dosage, and Safety

Mebendazole Tablets: Uses, Dosage, and Safety

Mebendazole tablets are a widely prescribed medication for the treatment of various parasitic infections, including pinworms, roundworms, and hookworms. This comprehensive guide aims to provide a detailed understanding of mebendazole 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 mebendazole tablet therapy.

Understanding Parasitic Infections

Types of Parasitic Infections

Causes and Transmission of Parasitic Infections

Impact on Global Health

Introduction to Mebendazole Tablets

What are Mebendazole Tablets?

Mechanism of Action

Available Brands and Forms of Mebendazole Tablets

Medical Uses of Mebendazole Tablets

Treatment of Intestinal Parasitic Infections

Management of Tissue Parasitic Infections

Off-Label Uses of Mebendazole Tablets

Dosage and Administration

Recommended Dosage for Different Infections

Dosage Forms and Strengths of Mebendazole Tablets

Administration Techniques and Instructions

Monitoring and Adjusting Dosage

Potential Side Effects and Precautions

Common Side Effects of Mebendazole Tablets

Rare but Serious Side Effects

Precautions and Contraindications

Drug Interactions with Mebendazole Tablets

Safety Considerations and Special Populations

Safety Guidelines for Pregnant and Breastfeeding Women

Use of Mebendazole Tablets in Pediatric Patients

Geriatric Considerations and Dosage Adjustments

Managing Mebendazole Tablets in Patients with Comorbidities

Monitoring and Management

Regular Check-ups and Laboratory Tests

Assessing Treatment Response and Adjusting Therapy

Adherence and Follow-up Recommendations

Lifestyle Considerations and Self-Care

Hygiene Practices and Preventing Reinfection

Dietary Considerations for Parasitic Infections

Educating Communities and Promoting Awareness

Frequently Asked Questions about Mebendazole Tablets

Can Mebendazole Tablets Cure Parasitic Infections?

How Long Can Mebendazole Tablets Be Used?

Are Mebendazole Tablets Safe for Long-Term Use?

Can Mebendazole Tablets Be Used in Combination with Other Medications?

Emerging Trends and Future Directions

Advances in Diagnosis and Treatment Monitoring

Development of New Antiparasitic Drugs

Community-Based Intervention Programs

Conclusion

Mebendazole tablets play a vital role in the treatment of parasitic infections, offering effective relief and control over these conditions. By understanding their uses, dosage, potential side effects, and safety considerations, patients and healthcare professionals can make informed decisions regarding their therapy. Adherence to the recommended dosage, hygiene practices, and regular monitoring are crucial for successful treatment outcomes. Additionally, raising awareness and implementing community-based intervention programs can contribute to the control and prevention of parasitic infections. With this comprehensive guide, you are equipped with the knowledge needed to navigate the world of mebendazole tablets confidently.

MANUFACTURING PROCEDURE OF MEBENDAZOLE TABLETS

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

SCOPE: This procedure 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: MEBENDAZOLE TABLETS, BATCH SIZE:  100000 TABLETS

EXPIRY DATE: AFTER 27 MONTHS   FROM THE DATE OF MANUFACTURING

COMPOSITION: 

Each uncoated Tablet contains: Mebendazole  U.S.P.  100 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

RAW MATERIAL:-

PACKING MATERIAL:- 

MANUFACTURING SPECIFICATION:

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

Average weight of each Tablet 180 mg. Weight Variation Limit for average weight of 20 tablets is +5 %.

Friability limit for 10 Tablets is not more than 1.0 %.

Hardness of the Tablets varies between 2-4 kg/cm².

Disintegration time for each Tablet is not more than 30 minutes.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚ C.

Yield:

Theoretical Yield 100000 Tablets.

Expected Practical Yield is 100000 +_ 7.5 %

Packing Details:

Put 1000 tablets in each polybag.

Seal each polybag along with the label.

Pack such 01 polybag in specified Plastic box.

Pack such 100 plastic boxes in C.box B-03 to give a pack size of 100×1000’s tabs.

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

MANUFACTURING PROCESS:

Preparation of Starch Paste:

Prepare the starch paste in the manner given below using a Steam steam-jacketed starch Paste Preparation Tank by operating it, Dissolve 0.030 kg of M.P.B.S and 0.010 kgs of P.P.B.S in 1Ltr of Purified water and stir continuously.

Add 4.0 kgs of Starch in 4 Ltrs of Purified water and stir continuously to make a smooth slurry.

Take 40 Ltrs of boiling water and add the solution of M.P.B.S and P.P.B.S and starch slurry with constant stirring to get a uniform paste.

Sifting:

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

Blending:

Blend the following ingredients using the Roto Cube Blender by operating it for 60 minutes and collect in Stainless Steel Container. 

10.20 kg of Mebendazole

1.00 kg of Lactose.

1.00 kg of Di Calcium Phosphate

Wet Granulation:

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

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

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 as per its SOP at a temperature of 60⁰ to 70⁰ C for 30 minutes. Cool the granules to room temperature. Repeat the same process for the next lots.

Sifting:

Fit Stainless Steel Sieve # 20 on the Sifter-II as per its SOP. Sift all the ingredients 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 as per its SOP and resift them.

Check the total weight of dried granules. Determine the loss on drying and the percentage yield of dried granules.

 Lubrication:

Add the following lubricating agents to the Roto Cube Blender and operate it for 30 minutes. Collect the blended powder in Stainless Steel Container

• 200 kgs of Talcum
• 050 kgs of Magnesium Stearate
• 500 kgs of starch
• 025 kgs of Aerosil

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 as per its SOP and collect the compressed tablets in a Stainless Steel Container.

Inspection:

Transfer all the tablets to the tablet inspection machine and sort out the defective tablets by operating it as per its  SOP and collect the selected tablets in a Stainless Steel Container.

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.

Packaging of the next product should not commence until the IPQA has given the ‘Line Clearance’

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