Metoprolol Tartrate DC Granules are pharmaceutical formulation granules containing Metoprolol Tartrate in a controlled granular format intended for direct-compression applications. Metoprolol Tartrate is the tartrate salt of metoprolol and is used as an active pharmaceutical ingredient in oral formulations.
The USP-NF monograph identifies Metoprolol Tartrate with the molecular formula (C15H25NO3)2·C4H6O6 and molecular weight 684.81 g/mol. The USP definition specifies 98.0% to 102.0% Metoprolol Tartrate, calculated on the dried basis.
The DC designation refers to Direct Compression. Direct compression requires suitable material properties because particle-size distribution, flowability, density, compressibility, compactability and content uniformity can affect processing and final tablet quality. Research has demonstrated the use of direct compression for Metoprolol Tartrate immediate-release tablet formulations.
Metoprolol Tartrate DC Granules are a granulated formulation containing Metoprolol Tartrate together with selected pharmaceutical excipients. The granular format is designed to provide controlled physical characteristics for handling, blending and compression.
The finished granules should be distinguished from the Metoprolol Tartrate API. The API is a chemically defined substance, whereas the finished DC granules are a complete formulation containing the active ingredient and other formulation components.
The characteristics of the finished granules depend on API properties, excipient selection, granulation or particle-engineering process, particle-size distribution, moisture content and manufacturing conditions.
Metoprolol Tartrate has the molecular formula (C15H25NO3)2·C4H6O6 and molecular weight 684.81 g/mol. The USP-NF monograph lists CAS Number 56392-17-7 and specifies 98.0% to 102.0% content on the dried basis for the API substance.
For finished Metoprolol Tartrate DC Granules, the API assay should be determined using the validated analytical method applicable to the finished formulation. The API monograph requirement should not automatically be treated as the finished-granule assay unless the approved specification uses the same analytical basis.
Direct compression is a tablet manufacturing process in which a suitable powder or granular formulation is compressed directly into tablets.
Metoprolol Tartrate has been investigated in directly compressed immediate-release tablet formulations. One formulation study used microcrystalline cellulose, crospovidone and magnesium stearate and evaluated pharmacopoeial and physical quality characteristics including content uniformity, weight variation, disintegration and dissolution.
This demonstrates the importance of formulation composition and processing conditions when developing Metoprolol Tartrate formulations for compression.
For Metoprolol Tartrate DC Granules, important physical characteristics can include:
The actual acceptance criteria should be established from the approved finished-product specification.
Particle-size distribution is an important physical attribute of Metoprolol Tartrate DC Granules because particle size can influence flow, packing, blend uniformity and compression behavior.
D10, D50 and D90 can be used to characterize the particle-size distribution when these parameters are included in the product specification.
A controlled granule-size distribution can support consistent material handling and processing. However, specific particle-size limits should be based on actual manufacturing and analytical data rather than assigned as universal values.
Good flowability supports consistent transfer and die filling during tablet manufacturing.
Metoprolol Tartrate DC Granules may be evaluated using:
These parameters help characterize the physical behavior of the finished granular formulation.
Direct-compression research emphasizes that powder flow and compaction characteristics can significantly affect tablet manufacturing performance. The specific flow requirements for Metoprolol Tartrate DC Granules should therefore be established from the finished-product specification.
Compressibility and compactability are important for materials intended for direct compression.
Compressibility describes the response of the granular material to applied pressure, while compactability describes its ability to form a mechanically strong compact.
During development, Metoprolol Tartrate DC Granules may be evaluated for:
These characteristics depend on the complete formulation and manufacturing process.
Content uniformity is an important quality attribute for formulations containing Metoprolol Tartrate. Uniform distribution of the active ingredient throughout the granules can support consistent dosage-unit manufacturing.
Finished-product development may include blend and granule uniformity studies using validated sampling and analytical procedures.
The acceptance criteria should correspond to the approved product specification and applicable quality requirements.
Metoprolol Tartrate formulations can be developed with different release characteristics depending on formulation design.
Research has demonstrated directly compressed Metoprolol Tartrate immediate-release tablets and evaluated their dissolution profiles.
The dissolution behavior of a finished Metoprolol Tartrate formulation depends on API properties, excipient composition, particle size, granule structure, compression force and other manufacturing variables.
Therefore, specific dissolution percentages or time points should only be published when supported by the validated finished-product specification.
Metoprolol Tartrate can be incorporated into different formulation systems. Research has investigated both immediate-release direct-compression formulations and modified-release systems using matrix polymers.
However, DC does not itself mean immediate release or sustained release. The release profile is determined by the complete formulation.
For a product specifically named Metoprolol Tartrate DC Granules, the page should focus on the direct-compression granular format unless the actual product specification establishes an additional release characteristic.
Moisture content can influence the physical characteristics of pharmaceutical granules, including flow, packing and compression behavior.
For Metoprolol Tartrate DC Granules, moisture should be controlled according to the approved product specification and supported by stability studies.
Packaging and storage conditions should be established according to validated stability data and the characteristics of the finished formulation.
Quality control of Metoprolol Tartrate DC Granules should cover chemical identity, assay, purity and physical processing characteristics.
Potential quality attributes include:
The USP-NF API monograph specifies Metoprolol Tartrate at 98.0% to 102.0% on the dried basis.
This API requirement should be distinguished from the finished-product specification for Metoprolol Tartrate DC Granules.
Development of Metoprolol Tartrate DC Granules can involve systematic evaluation of the active ingredient, excipients and physical properties of the granular formulation.
Important development studies may include:
Research on Metoprolol Tartrate formulations shows that excipient selection and manufacturing method can influence tablet quality and dissolution behavior.
Metoprolol Tartrate DC Granules may be considered for:
The final application and performance should be established through product-specific formulation development and validation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white granules |