MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS
Phenylephrine Hydrochloride, Cetirizine Dihydrochloride, Paracetamol, and Caffeine Anhydrous Tablets: Uses, Dosage, and Safety
Phenylephrine hydrochloride, cetirizine dihydrochloride, paracetamol, and caffeine anhydrous tablets are a commonly used combination medication for the relief of allergy symptoms, nasal congestion, pain, and fever. This comprehensive guide aims to provide a detailed understanding of these 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 the usage of these tablets.
Understanding Allergies and Common Cold
Types of Allergic Reactions and Symptoms
1.2 Causes and Triggers of Allergies
1.3 Common Cold: Symptoms and Duration
Introduction to Phenylephrine Hydrochloride, Cetirizine Dihydrochloride, Paracetamol, and Caffeine Anhydrous Tablets
2.1 What are These Combination Tablets?
2.2 Mechanism of Action of Each Component
2.3 Available Brands and Forms of These Tablets
Medical Uses of the Combination Tablets
3.1 Relief of Allergy Symptoms
3.2 Nasal Congestion Relief
3.3 Pain and Fever Management
3.4 Off-Label Uses of the Combination Tablets
Dosage and Administration
4.1 Recommended Dosage for Different Age Groups
4.2 Dosage Forms and Strengths of the Combination Tablets
4.3 Administration Techniques and Instructions
4.4 Monitoring and Adjusting Dosage
Potential Side Effects and Precautions
5.1 Common Side Effects of the Combination Tablets
5.2 Rare but Serious Side Effects
5.3 Precautions and Contraindications
5.4 Drug Interactions with the Combination Tablets
Safety Considerations and Special Populations
6.1 Safety Guidelines for Pregnant and Breastfeeding Women
6.2 Use of the Combination Tablets in Pediatric Patients
6.3 Geriatric Considerations and Dosage Adjustments
6.4 Managing the Combination Tablets in Patients with Comorbidities
Monitoring and Management
7.1 Regular Check-ups and Follow-up Appointments
7.2 Assessing Treatment Response and Adjusting Therapy
7.3 Adherence and Self-Monitoring Recommendations
Lifestyle Considerations and Self-Care
8.1 Environmental Allergen Control Measures
8.2 Pain and Fever Management Techniques
8.3 Educating Others about Allergies and Medication Usage
Frequently Asked Questions about the Combination Tablets
9.1 Can These Tablets Cure Allergies or the Common Cold?
9.2 How Long Can These Tablets Be Used?
9.3 Are These Tablets Safe for Long-Term Use?
9.4 Can These Tablets Be Used with Other Medications?
Emerging Trends and Future Directions
10.1 Advances in Allergy and Cold Symptom Relief
10.2 Development of Targeted Therapies for Allergies and Pain Relief
10.3 Patient Education and Allergy Awareness Programs
Conclusion
Phenylephrine hydrochloride, cetirizine dihydrochloride, paracetamol, and caffeine anhydrous tablets provide relief from a range of symptoms, including allergies, nasal congestion, pain, and fever. 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, precautions, and regular monitoring are crucial for successful treatment outcomes. Additionally, incorporating lifestyle measures and promoting allergy and pain management techniques can contribute to overall well-being. With this comprehensive guide, you are equipped with the knowledge needed to navigate the world of these combination tablets confidently.
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:
PHENYLEPHRINE HYDROCHLORIDE, CETIRIZINE DIHYDROCHLORIDE, PARACETAMOL & CAFFEINE ANHYDROUS TABLETS, BATCH SIZE: 500000
EXPIRY DATE: AFTER 27 MONTHS FROM THE DATE OF MANUFACTURING
COMPOSITION: Each uncoated Tablet contains:
PHENYLEPHRINE HYDROCHLORIDE B.P. 5 mg
CETRAZINE DIHYDROCHLORIDE B.P. 2 mg
PARACETAMOL B.P. 500 mg
CAFFEINE ANHYDROUS B.P. 15 mg
COLOUR: PONCEAU 4 R
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:-
| INGREDIENTS | Overages % | Total Quantity Used |
| Phenyl Epherine Hydrochloride | 2.00 | 2.625 kgs. |
| D.C.P. | 8.000 kgs | |
| Lactose | 5.000 kgs | |
| Magnesium Stearate | 1.500 kgs | |
| Sodium Benzoate | 0.500 kgs | |
| PVPK-30 | 0.800 kgs | |
| Starch | 16.00 kgs | |
| Starch | 0.500 kgs | |
| Starch | 5.000 kgs | |
| Ponceu- 4R Colour | 25.000 kgs | |
| Talcum | 3.000 kgs | |
| Aerosil | 0.500 kgs | |
| Caffeine Anhydrous | 5 | 7.875 kgs |
| Paracetamol | 5 | 262.500 kgs |
| Cetrazine Hydrochloride | 5 | 1.050 kgs |
PACKING MATERIALS:-
| NAME OF THE MATERIAL | TOTAL QUANTITY USED |
| ADHESIVE TAPE ROLL BROWN | 1.0 NOS |
| 4 TAB UNIT CARTON | 13095.00 NOS |
| 50 X 4 TAB OUTER CARTON | 260.00 NOS |
| C.BOX (470 X460 X 465) | 5.00 NOS |
| CELL TAPE ROLL | 1.00 NOS |
| CUREFLU STRIP FOIL (BACK) SILVER | 1.00 KGS |
| STRIP FOIL (BACK) TRANSPARENT | 1.00 KGS |
| CUREFLU STRIP FOIL(FRONT) SILVER | 1.00 KGS |
| STRIP FOIL ((FRONT) TRANSPARENT | 1.00 KGS |
MANUFACTURING SPECIFICATION:
The moisture content of powder should be less than 2.0 %.
Average weight of each Tablet 600 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 500000 Tablets.
Expected Practical Yield is 500000 ± 5 %
Packing Details:
Use Aluminium strip for strip packing.
Strip Pack the inspected and De-dusted tablets by using a Strip Packing Machine.
Put 1 strip each containing 4 tablets in each unit carton along with the literature and applicator.
Put such 10 unit cartons in each outer carton.
Seal each outer carton from both ends with cello tape.
Pack 30 outer cartons in a specified Box to give a pack size of 20 x 50 x 4 tablets.
Seal the 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 a Steam Jacketed Starch Paste Preparation Tank by operating it Dissolve 0.030 kg of M.P.B.S and 0.010 kg 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 a 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 the Rapid Mixer Granulator by operating it, Add the 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 at temperatures 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. 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 and resifting 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
- 0.200 kgs of Talcum
- 0.050 kgs of Magnesium Stearate
- 0.500 kgs of starch
- 0.025 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 and collecting 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 their SOP and collect the selected tablets in a Stainless Steel Container.
Strip Packing:
Shift the inspected tablets to the packing section and strip pack them using the Strip Packing Machine by operating it as per its SOP.
Weight Variation: I) Intermittently weight variation of compressed tablets should be checked at 30-minute 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’
