Excipients used in tablet formulation may be classified into two groups: Those that help to impart satisfactory processing and compression characteristics to the formulation e.g. bulking agents/diluents, binders, glidants, and lubricants .
What is formulation excipients?
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as “bulking agents”, “fillers”, or “diluents”), or to confer a ...
What are the types of excipients?
- Antioxidants.
- Binders. Dry binders. Wet or Solution binders.
- Coating Agents.
- Colours and Pigments. Dyes. Lakes.
- Bulking Agents / Dilutents / Fillers.
- Disintegrants.
- Emollients.
- Emulsifying agents.
What are excipients used in tablets define and give examples?
Excipients are inert substances used as diluents or vehicles for a drug . In the pharmaceutical industry it is a catch-all term which includes various sub-groups comprising diluents or fillers [1-9], binders or adhesives, disintegrants, lubricants, glidant, flavors, colors and sweeteners.
What is excipients in tablets?
Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action , but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability.
Are excipients harmful?
Generally, pharmaceutical excipients have been considered to be pharmacologically inactive and safe . Some pharmaceutical excipients have been associated with toxicity in neonates. The extent of excipient use in neonatal medicines is still poorly studied.
What are the importance of pharmaceutical excipients?
Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients . It can interact with the active ingredients and alter the medicament characteristics.
What are the types of dissolution?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type , reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
What are the types of dissolution instruments?
There are seven USP-defined types of dissolution apparatus: baskets, paddles, reciprocating cylinders, flow through cells, paddle over disk types, cylinders, and reciprocating holders . Although USP 2 paddles are most widely used, most dissolution apparatus incorporate any number of each type (often all of them) .
What is the formulation of a tablet?
Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. It comprises a mixture of active substances and excipients , usually in powder form, pressed or compacted from a powder into a solid dose. Tablets are prepared either by molding or by compression.
Can excipients cause side effects?
ADVERSE EFFECTS OF EXCIPIENTS. Adverse effects due to excipients in drug formulations are generally uncommon but the potential for toxicity is increased at high mg per kg doses especially in neonates and infants. Dose related toxicity and hypersensitivity reactions are well documented in the literature.
What is required for an excipient?
In order to market an excipient, there is no regulatory requirement that there must be a compendial monograph for the material. ... However, other regulations may define a suitable quality which could be used (e.g. Food Chemical Codex).
What are binders in tablets?
Binder excipients hold the ingredients of a formulation together , for example in a tablet. Binders ensure that tablets, powders, granules and others can be formed with the required mechanical strength. Moreover, they give volume to low active dose tablets. Binders are usually: Microcrystalline Cellulose.
What are disintegrants give examples?
There are two classes of disintegrants: traditional disintegrants, such as starch , and super disintegrants, which include croscarmellose sodium, crospovidone, and sodium starch glycolate. Currently, these three supper disintegrants are the most popular disintegrants.
What are the types of tablets?
- a. Compressed tablets.
- b. Sugar-coated Tablets.
- c. Film-Coated Tablets.
- d. Effervescent Tablets.
- e. Enteric-coated Tablets.
- f. Chewable Tablets.
- g. Buccal and Sublingual Tablets.
What is the difference between diluent and filler?
A diluent (also referred to as a filler, dilutant or thinner) is a diluting agent. Certain fluids are too viscous to be pumped easily or too dense to flow from one particular point to the other . This can be problematic, because it might not be economically feasible to transport such fluids in this state.
