Excipient:

1. CMC Cellogen FSH

Functional Category
Coating agent; stabilizing agent; suspending agent; tablet and capsule disintegrant; tablet binder; viscosity-increasing agent; water-
absorbing agent.
Applications in Pharmaceutical Formulation or Technology
Carboxymethylcellulose sodium is widely used in oral and topical pharmaceutical formulations, primarily for its viscosity-increasing
properties. Viscous aqueous solutions are used to suspend powders intended for either topical application or oral and parenteral
administration.(1,2) Carboxymethylcellulose sodium may also be used as a tablet binder and disintegrant,(3–6) and to stabilize
emulsions.(7,8) Higher concentrations, usually 3–6%, of the medium-viscosity grade are used to produce gels that can be used as the base
for applications and pastes; glycols are often included in such gels to prevent them drying out. Carboxymethylcellulose sodium is also
used in self-adhesive ostomy, wound care,(9) and dermatological patches as a muco-adhesive and to absorb wound exudate or
transepidermal water and sweat. This muco-adhesive property is used in products designed to prevent post-surgical tissue adhesions;(10-
12) and to localize and modify the release kinetics of active ingredients applied to mucous membranes; and for bone repair.
Encapsulation with carboxymethylcellulose sodium can affect drug protection and delivery.(6,13) There have also been reports of its use
as a cyto-protective agent.(14,15) Carboxymethylcellulose sodium is also used in cosmetics, toiletries,(16) surgical prosthetics,(17) and
incontinence, personal hygiene, and food products.
2. Colloidal Sillicon Dioxide
Functional Category
Adsorbent; anticaking agent; emulsion stabilizer; glidant; suspending agent; tablet disintegrant; thermal stabilizer; viscosity-increasing
agent.
Applications in Pharmaceutical Formulation or Technology
Colloidal silicon dioxide is widely used in pharmaceuticals, cosmetics, and food products; see Table I. Its small particle size and large
specific surface area give it desirable flow characteristics that are exploited to improve the flow properties of dry powders(1) in a number
of processes such as tableting(2–4) and capsule filling. Colloidal silicon dioxide is also used to stabilize emulsions and as a thixotropic
thickening and suspending agent in gels and semisolid preparations.(5) With other ingredients of similar refractive index, transparent gels
may be formed. The degree of viscosity increase depends on the polarity of the liquid (polar liquids generally require a greater concentration
of colloidal silicon dioxide than nonpolar liquids). Viscosity is largely independent of temperature. However, changes to the pH of a system
may affect the viscosity; In aerosols, other than those for inhalation, colloidal silicon dioxide is used to promote particulate suspension,
eliminate hard settling, and minimize the clogging of spray nozzles. Colloidal silicon dioxide is also used as a tablet disintegrant and as an
adsorbent dispersing agent for liquids in powders.(6) Colloidal silicon dioxide is frequently added to suppository formulations containing
 lipophilic excipients to increase viscosity, prevent sedimentation during molding, and decrease the release rate. Colloidal silicon dioxide
is also used as an adsorbent during the preparation of wax microspheres;(9) as a thickening agent for topical preparations;(10) and has been
used to aid the freeze-drying of nanocapsules and nanosphere suspensions.(11)
3. Mannitol
Functional Category
Diluent; plasticizer; sweetening agent; tablet and capsule diluent; therapeutic agent; tonicity agent.
Applications in Pharmaceutical Formulation or Technology
Mannitol is widely used in pharmaceutical formulations and food products. In pharmaceutical preparations it is primarily used as a diluent
(10–90% w/w) in tablet formulations, where it is of particular value since it is not hygroscopic and may thus be used with moisture-sensitive
active ingredients.(1,2) Mannitol may be used in direct-compression tablet applications,(3,4) for which the granular and spray-dried forms
are available, or in wet granulations.(5,6) Granulations containing mannitol have the advantage of being dried easily. Specific tablet
applications include antacid preparations, glyceryl trinitrate tablets, and vitamin preparations. Mannitol is commonly used as an excipient
in the manufacture of chewable tablet formulations because of its negative heat of solution, sweetness, and ‘mouth feel’.(6,7) In lyophilized
preparations, mannitol (20–90% w/w) has been included as a carrier to produce a stiff, homogeneous cake that improves the appearance of
the lyophilized plug in a vial.(8–10) A pyrogen-free form is available specifically for this use. Mannitol has also been used to prevent
thickening in aqueous antacid suspensions of aluminum hydroxide (<7% w/v). It has been suggested as a plasticizer in soft-gelatin capsules,
as a component of sustained-release tablet formulations,(11) and as a carrier in dry powder inhalers.(12,13) It is also used as a diluent in
rapidly dispersing oral dosage forms.(14,15) It is used in food applications as a bulking agent. Therapeutically, mannitol administered
parenterally is used as an osmotic diuretic, as a diagnostic agent for kidney function, as an adjunct in the treatment of acute renal failure,
and as an agent to reduce intracranial pressure, treat cerebral edema, and reduce intraocular pressure. Given orally, mannitol is not absorbed
significantly from the gastrointestinal tract, but in large doses it can cause osmotic diarrhea; see Section 14.
4. Saccharin Sodium
Functional Category
Sweetening agent.
Applications in Pharmaceutical Formulation or Technology
Saccharin sodium is an intense sweetening agent used in beverages, food products, table-top sweeteners,(1) and pharmaceutical
formulations such as tablets, powders, medicated confectionery, gels, suspensions, liquids, and mouthwashes;(2) see Table I. It is also
used in vitamin preparations. Saccharin sodium is considerably more soluble in water than saccharin, and is more frequently used in
pharmaceutical formulations. Its sweetening power is approximately 300–600 times that ofsucrose. Saccharin sodium enhances flavor
systems and may be used to mask some unpleasant taste characteristics. Injection of saccharin sodium has been used to measure the
armto-tongue circulation time.
5. Sodium Benzoat
Functional Category
Alkalizing agent; antimicrobial preservative; buffering agent; disinfectant; emulsifying agent; stabilizing agent.
Applications in Pharmaceutical Formulation or Technology
Sodium borate is used in pharmaceutical applications similarly to boric acid (see Boric Acid). It has been used externally as a mild
astringent and as an emulsifying agent in creams.(1) It has also been used in lozenges, mouthwashes, otic preparations (0.3% w/v), and
ophthalmic solutions (0.03–1.0% w/v). Sodium borate has additionally been investigated in the prevention of crystal formation in freeze-
dried solutions.(2) Preparations of sodium borate in honey have historically been used as paints for the throat, tongue, and mouth, but
such use is now inadvisable because of concerns about toxicity in such applications; see Section 14. Sodium borate is also used in
cosmetics such as moisturizers, deodorants, and shampoos.
6. Sodium Citrate
Functional Category
Alkalizing agent; buffering agent; emulsifying agent; sequestering agent.
Applications in Pharmaceutical Formulation or Technology
Sodium citrate, as either the dihydrate or anhydrous material, is widely used in pharmaceutical formulations; see Table I. It is used in
food products, primarily to adjust the pH of solutions. It is also used as a sequestering agent. The anhydrous material is used in
effervescent tablet formulations.(1) Sodium citrate is additionally used as a blood anticoagulant either alone or in combination with other
citrates such as disodium hydrogen citrate. Therapeutically, sodium citrate is used to relieve the painful irritation caused by cystitis, and
also to treat dehydration and acidosis due to diarrhea