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@article{207467,
        author = {Alok Krishan Ojha and Dr.Anju Goyal},
        title = {Validation of the Manufacturing Process for Suzetrigine 50 mg Film-Coated Tablets: Assessment of Critical Process Parameters and Quality Attributes},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {3},
        pages = {1163-1171},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=207467},
        abstract = {Process validation is a cornerstone of pharmaceutical quality assurance, ensuring that manufacturing processes consistently produce drug products meeting predetermined quality standards. This research paper presents a comprehensive prospective process validation study of Suzetrigine 50 mg film-coated tablets, a novel selective Nav1.8 sodium channel blocker approved for the treatment of moderate-to-severe acute pain in adults. Three consecutive production-scale batches (each containing 100,000 tablets) were manufactured and evaluated to establish documented evidence that the manufacturing process consistently delivers a product meeting all predefined specifications.
Critical process parameters (CPPs) at each manufacturing stage—including dry mixing, wet granulation, fluid-bed drying, blending and lubrication, compression, film coating, and primary packaging—were systematically monitored and evaluated. In-process tests comprised blend uniformity (by HPLC), loss on drying, tablet dimensions (length, width, thickness), average weight, weight uniformity, friability, disintegration time, dissolution profile, and coating weight build-up. Finished product testing included identification by HPLC, uniformity of dosage units, dissolution at 30 minutes, and assay.
Results across all three validation batches demonstrated that blend uniformity (%RSD: 3.16, 3.90, 4.56), tablet dimensional attributes, friability (all <0.45%), disintegration time (all <7 minutes in finished product), dissolution (all batches >70% at 30 minutes), and assay values (98.9%, 100.0%, 99.9%) were consistently within established acceptance criteria. The coating process maintained microbiological purity, and the weight build-up (2.9–3.0%) was within specification. All finished product parameters complied with predetermined specifications. These findings confirm that the Suzetrigine tablet manufacturing process is robust, reproducible, and in a state of control, thereby providing a high degree of assurance of product quality.},
        keywords = {Suzetrigine, Process Validation, Nav1.8 Sodium Channel Blocker, Film-Coated Tablets, Critical Process Parameters, Quality Assurance, cGMP},
        month = {August},
        }