Nitroglycerin SR Pellets Manufacturer in India
Nitroglycerin SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets designed for incorporation into oral dosage forms where a controlled release profile of nitroglycerin is required. Nitroglycerin, also known as glyceryl trinitrate, is a nitrate compound used in pharmaceutical formulations requiring carefully controlled delivery.
Nitroglycerin has CAS Number 55-63-0, molecular formula C₃H₅N₃O₉, and molecular weight 227.09 g/mol. These values refer to the active pharmaceutical ingredient and should not be confused with the finished-pellet assay or active loading.
Commercial pharmaceutical pellet portfolios demonstrate several Nitroglycerin SR pellet loadings, including approximately 1.4%, 1.6%, 2.1%, 2.5% and 2.5% depending on the manufacturer and formulation. Since an exact strength is not confirmed in the current SDP product information available to us, the final SDP strength should be stated according to the approved product specification rather than assuming a market strength.
Nitroglycerin SR Pellets use a multiparticulate formulation approach in which the active ingredient is incorporated into spherical pharmaceutical pellets and the formulation is designed to control the rate of release.
The pellet system can provide several formulation advantages, including:
For sustained-release development, the release profile depends on factors such as active loading, pellet core composition, polymer selection, coating weight gain, coating uniformity, pellet size, porosity, manufacturing process and dissolution conditions.
Commercial Nitroglycerin pellet references demonstrate spherical pellet formats and capsule applications, while some suppliers report particle-size ranges such as 18/30 mesh or 14–20 mesh depending on the formulation. These should be treated as product-specific characteristics rather than universal Nitroglycerin pellet specifications.
Nitroglycerin is a low-dose active ingredient, so accurate active loading and content uniformity are particularly important during pellet manufacturing.
Published commercial examples include:
These are market references and should not be presented as SDP-available strengths unless confirmed by the current SDP product specification.
For the SDP product page, the available strength should be entered exactly according to the approved SDP formulation/COA.
Nitroglycerin SR Pellets are designed for sustained-release multiparticulate oral formulation development. The release-controlling system can be optimized to achieve the required dissolution behavior over the intended testing period.
Potential formulation applications include:
The final release profile is formulation-specific and should be established through appropriate dissolution and product-performance testing.
Spherical pellets are particularly suitable for capsule-filling applications because their flowability and relatively uniform particle distribution can support consistent fill-weight control.
Important characteristics for capsule filling include:
Nitroglycerin commercial pellet products are documented for use in capsule dosage forms, although the final capsule configuration depends on the formulation developer's requirements.
The sustained-release behavior of Nitroglycerin SR Pellets is primarily controlled through formulation design and release-controlling components.
Important formulation variables include:
A properly developed multiparticulate system can provide controlled release from individual pellets, helping establish a reproducible overall dissolution profile.
Finished-product dissolution limits should be specified according to the validated SDP product specification and should not be replaced with generic market values.
Because Nitroglycerin is generally incorporated at relatively low concentrations in pellet formulations, precise active loading and uniform distribution are important quality attributes.
The finished pellet specification should distinguish between:
API specification:
The pharmacopoeial or approved specification applicable to Nitroglycerin as a raw pharmaceutical ingredient.
Finished pellet specification:
The actual Nitroglycerin content, assay range, uniformity, moisture, physical properties and dissolution requirements applicable to the finished pellet formulation.
The finished-pellet assay should therefore be reported according to the validated SDP product specification rather than using the assay range of the raw API.
Nitroglycerin SR Pellets can be incorporated into multiparticulate formulation-development programs where controlled release, capsule filling and reproducible pellet performance are required.
During formulation development, manufacturers typically evaluate:
Process optimization is important because small changes in coating thickness, pellet size or formulation composition can affect the final release characteristics.
Swapnroop provides Nitroglycerin SR Pellets for pharmaceutical formulation applications, with focus on sustained-release multiparticulate technology, controlled active loading, pellet characteristics and formulation requirements.
As a Nitroglycerin SR Pellets Manufacturer in India, the product can be positioned for pharmaceutical companies, formulation developers and bulk procurement requirements. Nitroglycerin SR Pellets supplier-related searches can include Nitroglycerin Sustained Release Pellets, Nitroglycerin Pharmaceutical Pellets, Nitroglycerin SR Pellets Manufacturer India, Nitroglycerin Pellets Supplier India, Nitroglycerin Multiparticulate Pellets and related formulation-development terms.
Nitroglycerin SR Pellets can be supplied according to approved product and customer requirements, including:
Available strengths and packaging configurations should be confirmed against the current SDP product specification before publication.
| 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% |
| Water Content | NMT 1.0% |