Administration: This tablet is used for oral administration. The diphenhydramine is best as tablet as administration cause the ingredient is well absorbed by oral route. The other routes can cause irritating effect on the side of administration and can have adverse effect. Tablet is the best mean of oral administration.
Active Ingredients: Diphenhydramine hydrochloride 25 mg Purpose: It work as histamine H1 receptor antagonist. Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.Diphenhydramine is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson’s disease.Physical description: diphenhydramine hydrochloride is white or almost white crystalline powder. It is odorless with bitter numbing test.
The pH of the powder in aqueous solution is 4 – 6. Stability: Slowly darken on exposure to light. Stable under ordinary condition. Inactive ingredients: The following Excipients are used to compound the tablets:Carnauba wax, silicon dioxide, croscarmellose sodium, calcium phosphate dibasic, dehydrate, hypromellose, magnesium stearate, cellulose microcrystalline, polyethylene glycol, polysorbate, polyvinyl alcohol, talc, titanium dioxide, aluminum oxide.
Purpose of the excipients used in diphenhydramine tablets: Carnauba wax: it is obtained from the leaves of the copernicia prunifera palm grown in Brazil. It is nearly insoluble in water and ethanol. It is nontoxic and hypoallergenic. It is used as binding and coating purpose in tablet making.
Silicon dioxide: These compounds appear to be biologically inert. The FDA generally recognizes silicon dioxide as safe. In tablet making it is used as a glident to improve the flawbility of the powder.
It is also used as anticaking and absorbent and disintegrates.Croscarmellose sodium: it is a cross linked polymer of carboxymethyl cellulose sodium. It appears as white fibrous free flowing powder and is commonly used as disintegrate in tablet manufacturing. It helps the tablet break up in the intestinal tract after oral administration.
This enhanced the bioavailability of the drug through superior drug dissolution. Calcium phosphate dibasic dihydrate: Calcium phosphate dibasic dehydrate act as diluent. It gives the tablet extra mechanical strength. So the tablet shows low friability. It also acts as a compression excipient. This diluent also helps the tablet for easy handling and swallowing.
Hypromellose: it is also known as hydroxypropyl methylcellulose. It is used to coat the tablet cause it forms a thin film. It also is a rate-controlling polymer for sustained released dose form. This is a vegetarian coating for the tablets.Magnesium stearate: It is solid white powder at room temperature and commonly used as diluent with the active ingredients cause FDA recognized it as a inert powder in biological system.
Cellulose microcrystalline: it is a white free flow powder and inert substance and has great compressibility properties. It is used to compress the tablet in a good form.Polyethylene glycol: it is used as a lubricant. So the powders does not stick with the tablet punches and the ejection of tablet become easy.Polysorbate: commonly it is known as surfactant and increases the solubility of one agent in another. The main purpose of this excipient is to increase the solubility of the drugs.Polyvinyl alcohol: it is a water-soluble synthetic polymer.
It is used as a lubricant and stabilizing agent as well. Talc: Magnesium silicate when hydrated is most commonly known as talc. It is an anticaking agent and improves the powder flow in tablet compression.
Titanium dioxide: it is used to coat the tablets and protect the tablets from UV light damage. The titanium dioxide layer also serves as a white base coat on the tablet, which allows using to give some tablets a distinctive color. It is inert and nontoxic.Aluminum oxide: it is used as an adsorbent desiccating agent. It is also used as dispersing agent.