Tablet

 

Anti-capping

One of the benefits of L-HPC is to resolve “capping,” which is a typical problem in the tableting process. Several reports have highlighted that capping is caused by a high residual die-wall pressure during the tableting process. L-HPC reduces the residual die-wall force and ejection force during the tableting process. For this application we recommend that you use either LH-11 or NBD-020.
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Binder solution (wet granulation)

PHARMACOAT® and METOLOSE® can also be used as a binder for granulation. The fine particle size (average 50-70 μm) allows good mixture with the vehicle (lactose/cornstarch) and PHARMACOAT® and METOLOSE® is effective for fluidized bed granulation and high shear mixer granulation (dry-blend).
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Dry binder (direct compression & wet granulation)

Low-Substituted Hydroxypropyl Cellulose (L-HPC) has been used as a disintegrant for solid dosage forms for many years. This polymer is not water-soluble, but it swells by holding water molecules around hydroxypropyl groups that are distributed on the cellulose backbone. Shin-Etsu Chemical has developed a new grade NBD for the L-HPC family. This is chemically identical to the current L-HPC grades, but particle shape is physically designed to significantly improve binding capability.
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Enteric coating (solvent)

An enteric coating agent is used to protect drugs from degradation by gastric acid or to protect gastric mucosa from irritating drugs. Thus, an enteric coating agent is insoluble in gastric juice, and it immediately dissolves when the enteric preparation transfers to the small intestine. HPMCP (Hypromellose Phthalate) and Shin-Etsu AQOAT® (Hypromellose Acetate Succinate) is an introduction into the market as an alternative cellulose derivative for enteric coating.
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Enteric coating (aqueous & dry)

"Dry coating" is a unique technique in which the polymer powder is directly applied to tablets or granules and the powder layer coalesces to form a film quickly by curing. In 2000, a Japanese pharmaceutical company commercialized this technique using Shin-Etsu AQOAT® for the first time. This technique is applicable for both tablets and granules using a regular apparatus with a powder feeding system. Ask your sales representative for further information.
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Film coating

Film coatings of this type are now in widespread use throughout the world. Although drug properties are the key factor in medicinal formulations, the physical form or the finish of a preparation is also important. PHARMACOAT® is easy to use as a film coating material and gives an excellent finish. It is very versatile, and is suitable for many applications in the design of film-coated tablet formulations. PHARMACOAT® film has the tough and flexible characteristics of cellulose derivatives. Although PHARMACOAT® film is not brittle, as acrylic polymer is, addition of a plasticizer such as polyethylene glycol (PEG 6000) is effective when highly flexible film is required. When PHARMACOAT® film is used for film coating, sometimes titanium dioxide (TiO2) or talc is recommended to be added.
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Orally disintegrating tablet

Orally disintegrating tablets (ODT) differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole. The ODT serves as an alternative dosage form for patients who experience difficulty in swallowing or for where compliance is a known issue, and therefore an easier dosage form to take ensures that the medication is taken. NBD-022 is recommended for this application as it has the quickest disintegration and a better feeling in the mouth than the other NBD grades. Shin-Etsu has also developed a co-processed excipient especially for the ODT application, this excipient is named SmartEx. For further information on the product please contact us.
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Quick disintegration

For active ingredients with poor solubility and low wettability, you can use a higher amount of L-HPC to improve disintegration. As much as 20 - 40 % of L-HPC has been used in a tablet for this purpose. Despite such a high content, stability problems are not as significant as seen in other ionic disintegrants. In such applications, tablets disintegrate in very fine individual particles, so the dissolution is rapid and complete. For this application we would recommend that you use NBD-022 which has a low substitution of HPO content and which will give you a rapid disintegration.
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Sugar coating

PHARMACOAT® 904 is used as a binder for sugar coating instead of gelatin and gum Arabic. Data on these products will be provided on request.
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Sustained release (pH independent)

Hydrophilic matrix systems designed with water-soluble polymers, such as Hypromellose, were first introduced in the early 1970s. Hydrophilic matrix system have allowed more controllable and reproducible drug release by controlling the chemical and physical properties of the polymer. METOLOSE® SR (Hypromellose) is especially suitable for this application, and provides a genuine consistency in the final products.
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Taste masking

Taste making of bitter tasting drugs is a common issue in formulation development. Taste masking of fine granules is sometime a major challenge due to the delay in drug release and difficulty of the coating operation. You can use an aqueous coating using METOLOSE® SM-4 without a sticking problem and no delay of dissolution. If you require time release of API after lag time for 5-10 minutes after administration is a feature of the dissolution behavior of sugar coating and such coating is a suitable method for taste masking. Combination of PHARMACOAT® and enteric coating material, such as Shin-Etsu AQOAT® can also be coated on a tablet for taste masking effect.
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Pellet

 

Enteric coating (solvent)

An enteric coating agent is used to protect drugs from degradation by gastric acid or to protect gastric mucosa from irritating drugs. Thus, an enteric coating agent is insoluble in gastric juice, and it immediately dissolves when the enteric preparation transfers to the small intestine. HPMCP (Hypromellose Phthalate) and Shin-Etsu AQOAT® (Hypromellose Acetate Succinate) is an introduction into the market as an alternative cellulose derivative for enteric coating.
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Enteric coating (aqueous & dry)

"Dry coating" is a unique technique in which the polymer powder is directly applied to tablets or granules and the powder layer coalesces to form a film quickly by curing. In 2000, a Japanese pharmaceutical company commercialized this technique using Shin-Etsu AQOAT® for the first time. This technique is applicable for both tablets and granules using a regular apparatus with a powder feeding system. Ask your sales representative for further information.
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Film coating

Film coating sometimes is used to protect coated pellets or to prevent chemical interactions between active ingredients and excipients, however regular film coating agents such as PHARMACOAT® are difficult to use for pellet coating due to agglomeration during the fluid bed coating process. METOLOSE® SM-4, an extremely low viscosity methycellulose is useful for aqueous film coating of pellets since it is less sticky and water soluble.
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Pellet extrusion

As well as tableting, L-HPC is also applicable for pellet extrusion. Micronized grades (typically LH-31) are best suited for this application because smaller particles can easily pass through the screen. L-HPC provides wet mass with a “buffer effect” where the wet mass accepts a wider range of water content. L-HPC plasticizes wet mass and shows greater productivity (extrusion speed and yield). The final pellets show quick disintegration and better friability compared with non-L-HPC formulations.
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Powder layering

L-HPC 31 and 32 can also be used in powder layering the API, this can be carried out in a Centrifugal coater using a PHARMCOAT binder solution Again for further technical information please contact us.
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Sustained release (pH dependent)

Depending on the type of API which is formulated, HPMCP and Shin-Etsu AQOAT® is coating onto a pellet or tablet to get a sustained release dissolution profile, for more technical information please contact us.
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Taste masking

Taste making of bitter tasting drugs is a common issue in formulation development. Taste masking of fine granules is sometime a major challenge due to the delay in drug release and difficulty of the coating operation. You can use an aqueous coating using METOLOSE® SM-4 without a sticking problem and no delay of dissolution. If you require time release of API after lag time for 5-10 minutes after administration is a feature of the dissolution behavior of sugar coating and such coating is a suitable method for taste masking. Combination of PHARMACOAT® and enteric coating material, such as Shin-Etsu AQOAT® can also be coated on a tablet for taste masking effect.
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Liquid and others

 

Capsule making

HPMC has become a successful alternative gelatin material for two-piece capsules and becoming a popular alternative for vegetarians. HPMC capsules used for both industries pharmaceutical and dietary supplements. PHARMACOAT® can also be used to manufacture HPMC capsules, we have various grades of PHARMACOAT® that can help you optimizes your manufacturing process.
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Dispersing aid (for capsule filling)

The release of a drug is filled in hard capsules tends to be delayed because the materials in the capsules are clogged; this delay is especially significant for herbal medications. However, if L-HPC is used together with a drug as a filler, clogging can be prevented because L-HPC absorbs water and disintegrates in a shorter time, which results in the rapid release of the drug.
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Eye drops

Shin-Etsu has developed low fiber content for eye drop application; please contact our sales department for more technical information and samples.
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Film making

Transparent films are obtained by casting METOLOSE® solutions. Although METOLOSE® films are relatively rigid they can be made flexible by adding plasticizes such as glycerin, propylene glycol, sorbitol, and triethyl citrate. The film properties markedly depend on the moisture content.
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Solid dispersion

"Solid dispersion" is a technique to enhance bioavailability of poorly-soluble drugs by increasing solubility. For a typical method of preparation, the drug and polymer (carrier) are dissolved together in a common solvent and the solution is spray-dried or coated on some core formulations. The resulting solid is a "molecular matrix" of the polymer and the drug, which demonstrates a significantly greater solubility compared to the original solubility of the drug. It has been reported that in this application Shin-Etsu AQOAT® enhances solubility of a poorly-soluble drug more effectively than other pharmaceutical polymers.
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Suspending

METOLOSE® is available which will disperse in water to produce viscous colloidal solutions suitable for use as suspending agents. Methycellulose are non ionic and therefore stable over pH range of 3-11, and are compatible with many ionic additives.
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Thickening

METOLOSE® have been known for a long time and have found wide acceptance for liquid preparation as a thickener in aqueous systems, for example as suspension stabilizers for polymerisation reactions.
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