Granulation and it's importance in tablet manufacturing process..

 GRANULATION & IT’S IMPORTANCE IN TABLET MANUFACTURING PROCESS

Granulation process is an inevitable step in tablet manufacturing as it improves flow property and compressibility of powder mass intended for compression. Granulation prevents segregation of the constituents of the powder mix.

Granulation is the process in which primary powder particles are made to adhere to form larger, multi particle entities called granules. Pharmaceutical granules typically have a size range between 0.2 and 4.0 mm, depending on their subsequent use.

Granulation is so important in tablet manufacturing process because it:-

1. Improve fluidity

2. Decrease segregation of the powder components

3. Decrease dusting

4. Improve compressibility of the material

An ideal granulation will contain all the constituents of the mix in the correct proportion in each granule, and segregation of the ingredients will not occur.

Types of granulation

Basically two types of granulation technique, but also other technique is direct compression 

1.Dry granulation   2. Wet Granulation

N.B: Wet granulation mostly used in tableting process, but this also depend on that chemical nature which we used for tableting.....

Dry granulation

In dry granulation the primary powder particles are aggregated under high pressure. There are two main processes. Either a large tablet (known as a ‘slug’) is produced in a heavy-duty tableting press (a process known as ‘slugging’) or the powder is squeezed between two rollers to produce a sheet of material (‘roller compaction’).

In both cases these intermediate products are broken using a suitable milling technique to produce granular material, which is usually sieved to separate the desired size fraction. Dry granulation technique is applicable  for drugs which do not compress well after wet granulation, or those which are sensitive to moisture.

Wet granulation

Wet granulation involves the massing of a mix of dry primary powder particles using a granulating fluid. The fluid contains a solvent which must be volatile so that it can be removed by drying, and be non-toxic. Typical liquids include water, ethanol and isopropanol, either alone or in combination. The granulation liquid may be used alone or, more usually, as a solvent containing a dissolved adhesive (also referred to as a binder or binding agent) which is used to ensure particle adhesion once the granule is dry. Water is commonly used for economical and ecological reasons. Its disadvantages as a solvent are that it may adversely affect drug stability, causing hydrolysis of susceptible products, and it needs a longer drying time than do organic solvents. This increases the length of the process and again may affect stability because of the extended exposure to heat. The primary advantage of water is that it is non-flammable, which means that expensive safety precautions such as the use of flameproof equipment need not be taken. Organic solvents are used when water-sensitive drugs are processed, as an alternative to dry granulation, or when a rapid drying time is required. In the traditional wet granulation method the wet mass is forced through a sieve to produce wet granules which are then dried. A subsequent screening stage breaks agglomerates of granules and removes the fine material, which can than be recycled. Variations of this traditional method depend on the equipment used, but the general principle of initial particle aggregation using a liquid remains in all of  the processes.

Glossary of Terms

Compressibility – Compressibility is the ability of powder to decrease in volume under pressure.

Important abbreviations need to know every pharmacy students

ABBREVIATIONS FREQUENTLY USED IN PHARMACEUTICALS

N.B: Probably Most used terms may green color 

AHU: Air Handling Unit 

AQL: Acceptable Quality Level

API: Active Pharmaceutical Ingredients

GLP: Good Laboratories Practice

ICH: International Conference on Harmonization

ISO: International Standard Organization/ International Organization for Standardization

GMP: Good Manufacturing Practice

cGMP: Current Good Manufacturing Practice

TQM: Total Quality Management

WHO:  World Health Organization

WHA: World Health Assembly

BMR: Batch Manufacturing Records

BPR: Batch Packaging Records

FDA: Food and Drug Administration

FD & C: Food, Drug and Cosmetics

IPC: In-Process Control/ Check

CBA: Collective Bargaining Agent

MCA: Medicines Control Agency (Britain)

MCC: Medicine Control Council (Africa)

ICRS:  International Chemical Reference Substances 

IRO: Industrial Relations Ordinance

EEC:  European Commission;

ISO/TC: International Organization for Standardization Technical Committee

PDCA: Plan, Do, Check, Act

PIC: Pharmaceutical Inspection Convention

PIC/S: Pharmaceutical Inspection Co-operation Scheme

DQ: Design Qualification

IQ: Installation Qualification

OQ: Operational Qualification

PQ: Performance Qualification

ASL: Approved Suppliers’ List

VMP: Validation Master Plan

TRS: Technical Report Series

CRS: Chemical Reference Substances

HEPA: High Efficiency Particulate Air

SAL: Sterility Assurance Level

IU: International Unit

IUPAC: International Union of Pure and Applied Chemistry

ANOVA: Analysis of Variance

HEPA: High Efficiency Particulate Air

HPLC: High Performance Liquid Chromatography

ICDRA: International Conference of Drug Regulatory Authorities

TLC: Thin Layer Chromatography

GC: Gas Chromatography

PVC: Poly Vinyl Chloride

PVDC: Poly Vinyledene Chloride

ROPP: Rolled on Pilfer Proof

RCC: Reinforced concrete

FTIR: Fourier Transform Infrared spectroscopy 

LAL: Limulus Amebocyte Lysate

RO: Reverse Osmosis

WFI: Water for Injection

FIFO: First-in-first-Out

FEFO: First Expired, First Out

EEFO: Earliest Expiry, First Out

HACCP: Hazard Analysis and Critical Control Point

FIP: International Pharmaceutical Federation

INN: International Non-proprietary Names

IFPMA: International Federation of Pharmaceutical Manufacturers Associations

IPEC: International Pharmaceutical Excipients Council

UNICEF: United Nations Children’s Fund

WTO: World Trade Organization

PDG: Pharmacopoeial Discussion Group

GTDP: Good trade and distribution practice

DAR: Drug Administration Registration           

DMF: Drug Master File                                    

DRA: Drug Regulatory Authority

EOI: Expression of Interest

ILO: International Labor Organization

NPS: Nonpareil seed

EDM: Essential Drugs and Medicines

BAN: British Approved Names

USAN: United States Accepted Names

GSP: Good storage practice

   MOA: Method of analysis

COA: Certificate of analysis

UNAIDS: United Nations Programme on HIV/AIDS

UNFPA: United Nations Population Fund

ASEAN: Association of South Asian Nations

TPN: Total Parenteral Nutrition       

BFS: Blow, Fill, Seal Technique (Ampule Filling)

LDPE: Low Density Polyethylene

HDPE: High Density Polyethylene

PP: Polypropylene

HVAC: Heat, Ventilation and Air conditioning

PPIC: Production Planning & Inventory Control

PPI: Proton Pump Inhibitor            

o. d.: Once daily

b. i. d.: Twice daily

TOC: Total Organic Carbon

t. i. d.: Thrice daily

q. i. d.: Four times daily

PMN: Phenylmercuric Nitrate

PMA: Phenylmercuric Acetate

BAC:  Benzalkonium Chloride

PVDC: Polyvinylidene Chloride

NE: Not Established

PET: Polyethylene Terephthalate

FAO: Food and Agriculture Organization

EEC: European Commission

USAID: U.S. Agency for International Development

ICDDRB: International Centre for Diarrhoeal Disease Research, Bangladesh

IBC: Intermediate Bulk Container

AAS: Atomic Absorption Spectroscopy

ICP: Inductively Coupled Spectroscopy

IC: Ion Chromatography

TGA: Therapeutic Goods Agency (Australia)

MHRA: Medicines and Healthcare products Regulatory Agency (UK)

Pharmaceutical Equipments

Here i describe mostly used Pharmaceutical Equipment such as Production equipment, Quality control equipment specially which is very important necessary equipment i just try to describe for the newly pharmacy student.......so try to read and try to understand any publishing article........