Theophylline SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Theophylline. They are designed for formulation development where a controlled release profile from a pellet-based oral dosage form is required.
Theophylline exists in both anhydrous and monohydrate forms. The USP-NF monograph identifies CAS 58-55-9 for anhydrous Theophylline and CAS 5967-84-0 for Theophylline monohydrate. The molecular formula of anhydrous Theophylline is C₇H₈N₄O₂, with a molecular weight of 180.17 g/mol. USP defines Theophylline as containing NLT 97.0% and NMT 102.0% of Theophylline, calculated on the dried basis.
Commercial pharmaceutical pellet manufacturers list Theophylline SR Pellets with different active loadings. Current market references report presentations such as 40%, 50%, 70%, 73%, 75% and 80%, depending on the manufacturer and formulation. Therefore, these commercial values should not be treated as a universal specification or as an SDP strength unless confirmed by SDP.
Theophylline Sustained-Release Pellets are designed to provide controlled release of the active ingredient through suitable pellet formulation and, where applicable, functional coating systems.
The sustained-release profile can depend on active loading, pellet size, matrix or coating composition, coating weight gain, polymer characteristics and manufacturing parameters. Consequently, finished Theophylline SR Pellets should have product-specific specifications for assay, moisture, particle-size distribution and dissolution/release characteristics.
Commercial sources confirm that Theophylline SR Pellets Manufacturer India products are available at different active loadings, illustrating that the formulation and loading are manufacturer-specific.
Theophylline SR Pellets can be considered for:
Theophylline SR Pellets may be manufactured using suitable pelletization, layering and functional-coating technologies. Depending on the formulation, these processes can be used to establish the required pellet morphology, active loading, mechanical properties and release profile.
Important quality parameters may include:
These parameters should be established through the applicable finished-product specification rather than directly copied from the Theophylline API monograph.
Theophylline SR Pellets may be evaluated for:
The USP-NF Theophylline monograph specifies an API content range of 97.0%–102.0% calculated on the dried basis. This is an API specification and should not automatically be used as the finished-pellet assay specification.
The multiparticulate format provides a flexible platform for sustained-release formulation development. Individual pellets can be formulated and, where appropriate, coated to achieve the intended release characteristics.
Theophylline pharmaceutical pellets can therefore provide a convenient formulation platform for manufacturers developing sustained-release oral dosage forms.
Theophylline SR Pellets can be supplied in suitable pharmaceutical bulk packaging according to the approved product specification. Active loading, pellet size, release characteristics and packaging configuration should be confirmed against the final product specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |