DMR 15 MG + CPM 2 MG + PHENYLEPHRINE HCL 5MG SYRUP (PAAN FLAVOUR) (Oral Liquid) This is a three-part formulation of DMR, CPM and phenylephrine hydrochloride at appropriate strength for oral administration. This formulation is intended to have active-ingredients with different strengths and physical formulation combined in a single liquid dosage form, additional to active-ingredient strength uniformity, it has an additional sensory-development requirement that is associated with the unique paan flavour, which must be consistent from batch to batch. Pharmaceutical manufacturers building a diverse PCD Pharma Franchise range need control over liquid processing, flavour consistency and assurance of analytical quality.
The compounded form has DMR 15mg, CPM 2 mg, and phenylephrine hydrochloride 5 mg in the designated syrup presentation. The three ingredients are in different concentrations, so they will need to be accurately dispensed in a controlled manner to ensure that they are evenly distributed in the batch.
The syrup vehicle can consist of: Purified water, sweetening agents, viscosity inducing agents, flavoring substances, solubilizing agents, suitable preservatives if necessary and other excipients. As shown in the list of excipients the composition of the excipients will be specific for the authorized product.
In formulation development, we evaluate the solubility of each active ingredient, as well as its compatibility, in the desired vehicle. The goal is to create a liquid formulation that will remain stable and uniform in concentration, visual appearance, pH and viscosity during storage.
The production steps are determined by the physicochemical properties of the three active substances. The soluble parts may be prepared separately or added to an appropriate volume of the vehicle, then added to the main mass.
The CPM component at the lowest concentrations is most sensitive to the dispensing and mixing steps, where small differences in amount will have an impact on the isoconcentration distribution in the final formulation. Premixing/diluting a small amount during formulation development can help facilitate even distribution.
Phenylephrine hydrochloride and DMR are dispersed depending on their solubility and the compatibility. Speed of mixing, order of addition, temperature, time of process are monitored to get a uniform bulk.
The finished syrup is tested prior to filling to verify that the formulation conforms to the specified physical parameters.
The paan flavour is one of the unique ingredients within this formulation and has a slightly selective flavour development. The flavour system should be consistent without effecting physical or chemical stability of actives.
Sweetening agents and flavouring materials are selected in order to produce the desired sensory characteristics. The flavour components are present at relatively low levels and are selected or balanced in such a way that they do not alter viscosity, aroma or other physical characteristics.
The viscosity of liquid products is another critical factor, especially in liquid production. A good flow of the syrup will be easy to fill and use, keeping the structure during storage.
PH The pH can affect the stability and solubility of the active ingredients and is therefore included as part of formulation-development studies. The final pH range is determined using compatibility and stability studies.
The manufacturing process starts with the validation and precise weighing of DMR, CPM, phenylephrine hydrochloride and each of the excipients with full traceability. Raw materials are released to production based on the approved specifications.
In-process checks can include appearance, pH, viscosity, temperature, mixing conditions and bulk homogeneity. These controls can be applied to monitor the quality of the syrup during preparation and before it is filled.
Finished product testing may be as simple as the identification and assay of the individual active ingredients, pH, viscosity, microbial purity, fill volume, specific gravity where relevant, appearance or other product specific testing.
Method should be able to differentiate the three active ingredients in the same formulation. Suitable sample preparation and validated analytical procedures are helpful in determining the individual components.
Controlled raw-material specifications and uniform manufacturing procedures can also be used to manage flavour consistency.
For DMR 15 MG + CPM 2 MG + PHENYLEPHRINE HCL 5MG SYRUP, stability testing can be carried out to provide stability profile for assay, degradation products, pH, viscosity, colour, odour, flavour profile, microbial purity and other parameters over the intended shelf life.
Syrup/Vaccine Container(s) The packaging must serve to protect the liquid formulation from contamination. And sustain a compatible interface with the syrup vehicle. Pharmaceutical grade plastic or glass bottles can be considered subject to the stability requirements of the product.
This closure should allow for acceptable protection to leakage and the external environment. Fill-volume precision, cap integrity, interaction with the container and recovery can be evaluated during packaging development.
In stability studies, exposure to light and temperature may also be considered, depending on the sensitivity of the formulation and flavour system.
DMR 15 MG + CPM 2 MG + PHENYLEPHRINE HCL 5MG SYRUP (PAAN FLAVOUR) involves harmonized management of active-ingredient addition, liquid formulation, premixing, flavour addition, viscosity modifications, analytical testing, stability testing and packaging.
On behalf of PCD Pharma Franchise for this nature of flavour If pharmaceutical companies establish all relevant specifications such as favourable regulations, testing procedures, procedures for production, and relevant documentation, this special flavored syrup may be part of a PCD Pharma Franchise portfolio. Ongoing supply of active ingredients, consistent paan flavour preparation, reliable analytical testing, and proper packaging and documentation stability evaluation provide order of note for pharmaceutical syrup production.
DMR 15mg + CPM 2mg + Phenylephrine HCl 5mg Paan Flavour Syrup with formulation, manufacturing, quality control and packaging details.
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