Starcap 1500
Also known as: StarCap 1500, pregelatinized corn starch, modified starch, Partially Pregelatinized Maize Starch
Overview
StarCap 1500 is a partially pregelatinized maize (corn) starch, a pharmaceutical excipient derived from maize starch that has undergone mechanical and thermal processing. This process partially breaks down starch bonds, enhancing its functional properties without full gelatinization. It is primarily used in oral solid dosage forms like tablets and capsules, acting as a multifunctional filler-disintegrant. Its key characteristics include self-disintegrating properties, good flowability, and the ability to act as a binder without requiring heating during formulation. It is also considered "self-lubricating," which aids in capsule filling without the need for additional lubricants. StarCap 1500 is a well-established excipient with extensive research on its physicochemical and functional properties in pharmaceutical formulations.
Benefits
StarCap 1500 offers several benefits in pharmaceutical formulations. It enhances tablet tensile strength and mechanical integrity when combined with other excipients, contributing to the robustness of the final product. It provides consistent and reproducible disintegration times, which is crucial for predictable drug release. As a multifunctional excipient, it combines the roles of a filler, binder, and disintegrant, simplifying formulation design and potentially reducing the number of excipients needed. Additionally, it improves machinability and flow properties during capsule filling, which can reduce manufacturing variability. These benefits are formulation-dependent but have been shown to be statistically significant in controlled experimental studies. Its effects are immediate during manufacturing and upon ingestion of the dosage form.
How it works
StarCap 1500 functions as a pharmaceutical excipient, meaning it is pharmacologically inert and does not interact with biological pathways or body systems. Its mechanism of action is purely physical and chemical within the dosage form. As a filler, it adds bulk to tablets and capsules. As a binder, its partially pregelatinized nature allows it to form bonds between particles, contributing to tablet hardness and integrity without needing heat. As a disintegrant, it absorbs water and swells, causing the tablet or capsule to break apart rapidly in the gastrointestinal tract, thereby facilitating drug release. It is not absorbed by the body and passes through the gastrointestinal tract as an inert substance.
Side effects
StarCap 1500 is generally recognized as safe (GRAS) as a pharmaceutical excipient, being derived from food starch. No adverse effects have been reported in the literature related to its use in pharmaceutical formulations. There are no known common, uncommon, or rare side effects associated with its ingestion as an inactive ingredient. Furthermore, no drug interactions or contraindications have been identified. Its inert nature suggests broad safety across various populations, and no special considerations for specific populations have been noted. It is considered a safe and well-tolerated component of oral solid dosage forms.
Dosage
The dosage of StarCap 1500 is dependent on the specific pharmaceutical formulation and its intended purpose. It is typically used as a filler at concentrations ranging from 10% to 50% weight/weight (w/w) in tablets or capsules. While there isn't a minimum effective dose in a pharmacological sense, its functional properties become evident within these ranges. Optimal dosage ranges are formulation-specific; higher proportions can increase tablet strength but may also prolong disintegration time. A maximum safe dose is not established, as its use is limited by formulation requirements rather than safety concerns. It is incorporated during the manufacturing process, and there are no timing considerations for its administration. StarCap 1500 is suitable for direct compression tablets and as a filler in capsules. It is not absorbed by the body, so absorption factors are not relevant, and no cofactors are required for its function.
FAQs
Is StarCap 1500 safe for human consumption?
Yes, as an inert excipient derived from food starch, StarCap 1500 is widely used in pharmaceuticals and considered safe for human consumption.
Does it affect drug release?
Yes, by controlling tablet disintegration time and integrity, StarCap 1500 indirectly influences the kinetics and rate of drug release from the dosage form.
Can it replace multiple excipients?
Yes, StarCap 1500 is a multifunctional excipient that combines the properties of a filler, binder, and disintegrant, potentially simplifying formulation design.
Is it suitable for direct compression?
Yes, StarCap 1500 is specifically designed and well-suited for use in direct compression tablet formulations due to its functional properties.
Does it require special storage?
No, StarCap 1500 does not require special storage conditions beyond standard handling practices for pharmaceutical excipients.
Research Sources
- https://www.roquette.com/-/media/contenus-gbu/pharma/scientific-posters/roquette-pharma-case-study-partially-pregel-corn-starch-as-filler-2-pieces-hard-gelatin-capsules.pdf – This experimental formulation study by Roquette demonstrated StarCap 1500's effectiveness as a filler-disintegrant in hard gelatin capsules. It highlighted good machinability and consistent capsule fill weights, though noting that its friable powder structure could affect flow properties. The study provides high-quality data on the physical properties and performance of StarCap 1500 in pharmaceutical manufacturing.
- https://pubmed.ncbi.nlm.nih.gov/21469946/ – This experimental tablet formulation study investigated the impact of StarCap 1500 proportion on tablet properties. It found that increasing the concentration of StarCap 1500 led to increased tablet tensile strength and prolonged disintegration time, confirming its dual role in mechanical integrity and disintegration. The research provides robust data for understanding its behavior in pharmaceutical formulations.
- https://www.semanticscholar.org/paper/The-Use-of-Multifunctional-Starch-Based-Coprocessed-CompressionOlowosulu-Oyi/73408cd64b5233f84ae037f36d8e0717770a2a7d – This review article by Olowosulu & Oyi discusses the use of multifunctional starch-based excipients, including those with self-disintegrating properties like StarCap 1500. It supports the concept of such excipients offering multiple functionalities in pharmaceutical formulations. While a review, it contributes to the understanding of StarCap 1500's role as a versatile excipient.