(CordenPharma Photo) Variety of coated tablets in different sizes and colors.
Tablets are the most common and convenient dosage form due to their ease of administration, precise dosing, and patient compliance. As the last step before packaging, tablets, minitablets or multiparticulates may require an additional outer layer – known as a coating – to enhance their functionality, stability, and acceptability.
Why Are Tablets, Minitablets and Multiparticulates Coated?
- Aesthetic Appeal & Rapid Identification: Coatings can enhance the visual appearance of tablets and minitablets by providing uniform color, gloss, and branding, making products more attractive and recognizable to patients, and aiding in product differentiation.
- Ease of Handling in Manufacturing: Coated tablets and minitablets have smoother surfaces and generate less dust, which facilitates efficient handling on high-speed automatic filling and packaging equipment. The coating also minimizes manufacturing operator exposure to Highly Potent Active Pharmaceutical Ingredients (APIs), enhances workplace safety, reduces mechanical damage, and ensures consistent product quality during large-scale production.
- Protection: Coating provides a physical barrier that may shield the API from environmental factors such as moisture, light, and oxygen, thereby improving the stability and shelf-life of the product.
- Masking Taste & Odor: Many APIs have a bitter or unpleasant taste and odor. Coating masks these characteristics, making tablets and minitablets more palatable and increasing patient compliance, especially in pediatric and geriatric populations.
- Modified Drug Release: Specialized coatings enable the modification of drug release profiles such as delayed, extended, or targeted release, ensuring that the medication acts at the desired site and time within the gastrointestinal tract. Gastro-resistant coatings (also known as enteric coatings) are specialized film coatings designed to withstand the acidic environment of the stomach and only dissolve in the more neutral conditions of the small intestine. This technique protects acid-labile drugs and prevents gastric irritation by delaying drug release until the dosage form reaches the intestines.
Film coating is the most prevalent and popular method of applying an additional layer. It involves spraying a thin, uniform layer of polymer-based formulation onto the surface of a tablet, minitablet or multiparticulate core. The solvent (water or organic) evaporates, leaving a continuous film that provides the desired effect. The technology best-suited for film coating includes pan-coaters or fluidized-bed equipment, both of which rely on the principle that tablet cores need to enter a spray zone to be efficiently coated.
(CordenPharma Photo) – Pan coater installed in our new mid-size Highly Potent Oral Solid Dosage suite.
CordenPharma has long-term experience in functional coating development. Our team of experts helps you identify the best coatings for your target dosage applications – for example gastro-resistant tablets or taste-masking of pediatric oral solids like minitablets. We employ cutting-edge small-scale coating equipment to help rapidly identify the best options, using only a limited amount of your precious API and uncoated tablets. Along the same line, if you are not sure about the color of your tablet, small samples of different colors are prepared to help you in your decision making.
Subsequently, coating recipes and specifications are set, while processes are transferred and applied to clinical trial material or commercial scale manufacturing. CordenPharma has pan-coaters and fluidized-bed equipment in place to support your coating requirements at all scales.
Coating tablets is a critical step in pharmaceutical manufacturing, serving multiple purposes including protection, taste masking, controlled drug delivery, and aesthetic enhancement. Tablets with functional coating should not be split and are to be ingested entirely to preserve the integrity of functionality. Therefore, never split a tablet without reading the leaflet instructions or checking with an informed healthcare provider.
We support your API and Oral Solid Dosage Drug Product production during the entire lifecycle of your small molecule products, from early phase development, clinical supplies, late-stage registration and validation to commercial manufacturing and packaging. This full-service capability includes early-phase formulation screening that considers biopharmaceutic principles, formulation development that considers compatibility, performance and scalability, as well as process development, transfer, and characterization to reach filing readiness. Our experts take care to bring your molecules from preclinical through all clinical phases to market. Additionally, we handle APIs with OELs down to the picogram per cubic meter level.
