Opaspray M-1-711 1B is a chemical compound used in the film coating of tablets as a colouring agent. Various other chemical compounds are found in its composition: Water, Titanium Dioxide, Hydroxypropyl Methylcellulose are generally always present. An alcohol is also included, which may be methylated ethyl alcohol or SDA Specially Denatured Alcohol CAS 64-17-5, as well as a colouring lacquer.

The name describes the structure of the molecule

• "Opaspray" i is typically a trade name indicating a coating or colorant used in the pharmaceutical industry, especially for tablet coatings.
• "M-1-711 1B" refers to a specific formula or variant of the Opaspray product

Description of raw materials used in production

• Water. Serves as a solvent or vehicle in many coating formulations.
• Titanium Dioxide. A white pigment used to provide opacity and color to the coating.
• Hydroxypropyl Methylcellulose (HPMC). A water-soluble polymer used as a film-former in the coating.
• Methylated ethyl alcohol. A volatile solvent used to aid in the dispersion of ingredients and in evaporation during the drying process.

The procedure of application on tablets takes place in several stages:

• Selection of ingredients. The first step in the preparation of a coating is the selection of ingredients. This includes a polymer (which forms the film), a plasticizer (which helps the film to remain flexible), a pigment (which provides the color) and other additives if necessary.
• Preparation. The ingredients are mixed to form a coating solution that leads to the dissolution of the polymer and other ingredients in a suitable solvent to form a homogeneous solution.
• Application of the coating. The coating solution is then applied to the tablets or other dosage forms using a fluidized coating medium. The coating solution is sprayed onto the tablets as they are produced and the solvent is then evaporated to leave a thin film of the coating.
• Drying and curing. After application of the coating, the tablets are dried. Curing involves heating the tablets to a specific temperature for a certain period of time to ensure that the coating is fully adapted.
• Quality control. The final product is tested to ensure it meets the required specifications. This may involve testing for parameters such as coating thickness, color and gloss.

Opaspray is responsible for the significant change in the thermomechanical behaviour of hydroxypropyl methylcellulose (1).

For more information:    Opaspray studies

References_________________________________________________________________________

(1) Masilungan, F. C., & Lordi, N. G. (1984). Evaluation of film coating compositions by thermomechanical analysis. I. Penetration mode. International journal of pharmaceutics, 20(3), 295-305.

Compendium of the most significant studies with reference to properties, intake, effects.

Niu, F., Haslam, J., Rajewski, R., & Subramaniam, B. (2012). A fluidized-bed coating technology using near-critical carbon dioxide as fluidizing and drying medium. The Journal of Supercritical Fluids, 66, 315-320.

Abstract. A Wurster-type coater employing near-critical carbon dioxide as the fluidizing medium and antisolvent was developed for pharmaceutical applications. Suitably designed glass inserts housed in a high-pressure chamber allow for the controlled fluidization and circulation of the substrates with dense CO2.

Thoennes, C. J., & McCurdy, V. E. (1989). Evaluation of a rapidly disintegrating, moisture resistant lacquer film coating. Drug Development and Industrial Pharmacy, 15(2), 165-185.

Abstract. Simplex optimization was used during the development of a rapidly disintegrating, moisture resistant lacquer film coating. A hygroscopic aniomic exchange resin with the capability of adsorbing four to five times its weight in water was used as the model drug. The coating variables investigated included levels of magenesium stearate, talc, hydroxypropylmethylcelluslose (5 cps), polyethylene glycol 8000, Opaspray, and Eudragit E30D.

Dansereau, R., Brock, M., & Redman-Furey, N. (1993). The solubilization of drug and excipient into a hydroxypropyl methylcellulose (HPMC)-based film coating as a function for the coating parameters in a 24” accela-cota®. Drug development and industrial pharmacy, 19(7), 793-808.

Abstract. In this study, a 23 orthogonal factorial design was used to study the migration of drug and stearic acid from a tablet to an aqueous-based cellulose coating solution. The independent variables evaluated were atomization air pressure, inlet air temperature, and spray rate.

Moyer, S. (1986). 9: Pharmacokinetics of Naproxen Sodium. Cephalalgia, 6(4_suppl), 77-80.