Types of granulation in tablet formulation

TYPES OF GRANULATION
Granulation can be achieved by three method as follows :-
1. Direct compression   
      Crystalline substance like sodium chloride, sodium bromide may be compressed directly. The vast majority of medicinal agents are rarely so easy to tablet, direct compression material should posses good flow and compresibility and must be inert, tasteless, able to disintegrate and inexpensive.
Method
(Drug + filler + disintegrant + lubricant + glidant ) all are blend directly after sifting through Viber sifter and compressed


2. Dry Granulation
   It is used in situations where effective dose of a drug is too high for direct compaction and the drug is sensitive to heat, moisture, or both which preclude wet granulation. This is also called slugging method.
Method
A.      (Drug + filler + lubricant) All are.       blend then precompression done and     after that   comminution done
 
 B.  (glidant + lubricant + disintigrant)  sizing then blend with A

3. Wet Granulation
  Wet granulation forms the granules by binding the powders together with an adhesive, instead of by compaction. Liquid bridge are developed between particles, and the tensile strength of these bond increase as the amount of liquid binder added is increased. A drying process is required in all wet granulation to remove the solvent and to reduce the moisture content. After drying granulation is screened again, followed by compression.

Schematic drawing of All types granulation

WHAT IS BMR ( BATCH MANUFACTURING RECORD )?

WHAT IS BMR ( BATCH MANUFACTURING RECORD )?

Batch manufacturing record is a written document of the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step.

There are several stages of the pharmaceutical tablet manufacturing process. All stages are included in the batch manufacturing record from issuance of the raw material to the final packaging. Every batch has a separate BMR having the batch history of batch production. Documents and the proofs are attached in the BMR during the manufacturing process.

A good Batch Manufacturing Record format should contain following parts:

1. Batch Record: Very first page of the BMR has all records about the batch as batch number, batch size, composition, master formula record referred, weight of the batch, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, date of starting and date of completion.

2. General Instruction for Manufacturing: Health and safety instructions to the operators and the manufacturing chemist are written those should be followed during the manufacturing process regarding the material and equipments used during manufacturing.

3. Equipment Cleaning Record: Checklist of the cleaning of all equipments is prepared; those are used in the manufacturing of the batch including the previous product, batch and date of cleaning. Cleaning of the equipments should be checked by the quality assurance.

4. Bill of Materials: List of the raw material should have the quantity of the materials with their AR numbers. Weights of the materials should be verified by quality assurance. If tablets are coated then coating material should be included.

5. Manufacturing Process: Manufacturing process should be written step by step in easy language. Milling, sifting, drying, lubrication, compression, coating and packing having all instruction with process time should be written. Checklist for line clearance should also be attached before starting every process.

After completion of the every stage, tablets must be checked for the compliance of the specification of that stage. Results should be attached with the batch manufacturing record.

6. Yield: Yield of the batch should be calculated at the end of every stage to calculate the process loss. Final yield should be calculated at the end of the manufacturing that should not be less than 99.00%.

7. Abbreviations: List of the abbreviations used in the document should be made to understand the BMR easily.

8. History of Chances: At the end, the document should have a list of the changes in the document including the revision number and the date of the change.

What is deviation ? What are the types of deviations?

What is deviation ? What are the types of deviations?

what is SOPs ? full form and defination of SOPs

what is SOPs ? full form and defination of SOPs

How to prepare a new SOPs?

standard operating procedure for cleaning of equipment and accessories in Production

standard operating procedure for cleaning of equipment and accessories in Production

SOP OF SOP PREPARATION

SOP OF SOP PREPARATION