Easy to use film coating material that provides an excellent finish
PHARMACOAT® is a versatile hypromellose
Shin-Etsu Chemical Co., Ltd. (Tokyo, Japan) developed PHARMACOAT® in the 1960s during the early days of film coating and since then it has been the subject of a continuous development and quality improvement.
The PHARMACOAT® grades are low viscous hypromellose substitution 2910 (also named as Hydroxy propyl methyl cellulose or HPMC). Hydroxypropoxy and methoxy groups are introduced on the cellulose backbone, resulting in a water-soluble cellulose derivative.
Several viscosity grades are available as shown in the table below and are compliant with the pharmacopoeias from USA, Japan and Europe:
A coating technique for high-friability tablets using PHARMACOAT® [P-011]
An advanced coating formulation with PVA and HPMC [P-012]
An organic coating method with PHARMACOAT®, with mixed solvent of high content of ethanol and water [P-009]
Application of L-HPC and PHARMACOAT® in twin screw granulation for continuous manufacturing [L-039]
Application of PHARMACOAT® as a carrier in solid dispersion [P-010]
Coating formulation for logo tablets [P-013]
Comparative study of wet granulation binders [P-017]
Dissolution behavior of various HPMC lower viscosity grades [P-014]
Effect of moisture content on the mechanical properties of cast HPMC films [P-005]
Effect of plasticizers and other additives on the mechanical properties of cast HPMC films [P-008]
Film properties of HPMC and MC [G-002]
Film properties of low-viscosity grade cellulose derivatives [G-011]
Oxygen permeability of low-viscosity grade cellulose derivatives [G-016]
Taste masking coating using Shin-Etsu AQOAT® and PHARMACOAT® with controlled release [A-63, P-018]
PHARMACOAT® as film coating material
The tablet coating using hypromellose became popular because it is an easy method to protect fragile tablets and provide a smooth surface of the coated tablets. Another advantage for the extensive use of PHARMACOAT® in coating applications is its solubility over the entire biological pH.
One of the main advantages using PHARMACOAT® grades in tablet or pellet coating is the ability of hypromellose to form transparent and flexible films from aqueous solutions.
PHARMACOAT® 606 is the most used grade for tablet coating, in case of fragile tablets, PHARMACOAT® 615 is recommended. On the other hand, PHARMACOAT® 603 is the preferable grade for pellet coating. Low viscous hydroxyl propyl methyl cellulose grades are also one of the major products used for capsules coating or capsules banding. The aim of this application is to seal the gap existing between the two parts of the capsules in order to avoid any liquid penetration.
In order to easy differentiated from each other oral solid dosage forms having the same shape, pigments can be added to the hypromellose film solutions. In that case, the film flexibility is decreased, for that reason we recommend to add plasticizers in the coating formulation. Furthermore, talc can be added to the coating formulation to optimise tablets slipping during the packaging or reduce the tackiness of tablets and pellets during the coating process.
PHARMACOAT® as binder for wet granulation
Hydroxy propyl methyl cellulose is an effective and widely used binder in wet granulation processes. It has superior stability due to its non-ionic character, and hence it does not interact with drugs. PHARMACOAT® 603 or 606 are used either in dry form or in the binding solution. Both are used in typical wet granulation processes like fluid bed granulation or high shear granulation. The obtained granules show an improved flow property compared to the initial powder. They can then be compressed into tablets or filled into capsules or directly into sachets.
PHARMACOAT® used as capsule shell
Hydroxy propyl methyl cellulose films show as well interesting properties for the manufacturing of hard capsules. Thus, low viscosity hypromellose is used to replace gelatine in this application. The main advantages over gelatine are the better moisture stability as hypromellose is less moisture sensitive and its plant derived origin. The optimal solution for patients who follow a vegetarian or vegan diet.
Shin-Etsu has around 20 Technical documents available regarding Hydroxy propyl methyl Cellulose for coating applications; such as:
• Solubility of PHARMACOAT® 606 in Alcohol-Water Mixtures • Effect of Plasticizers and other Additives on the mechanical properties of cast Hypromellose Films • among others…
Grades and applications
Application
Tablets & Pellets
Tablet coating
Pellet coating
Taste masking by coating with enteric polymer and pore former
Binder solution for wet granulation (WG)
Capsules
Capsule Shell
Amorphous Solid Dispersion (ASD)
Solvent free methods (HME)
Solvent methods
Liquid and Others
Dry syrup
Oral films
Continuous Manufacturing (CM) for Oral Solid Dosage Form (OSD)
The Shin-Etsu team is supporting all technical, quality and regulatory related questions. Our team of sales and technical sales manager supports you to develop your products, or during issues at your manufacturing process. Shin-Etsu has long year experience in cellulose ether business and is aiming to give you the best possible guidance and high quality products manufactured in Japan and Germany.
