Each ASITAGAB NT tablet comprises a fixed-dose combination of Gabapentin IP (1-(aminomethyl)cyclohexaneacetic acid) at a concentration of 400 mg and Nortriptyline Hydrochloride IP (3-(10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1-amine hydrochloride) at a concentration equivalent to 10 mg of Nortriptyline base. Manufacturing Synopsis: · The production of ASITAGAB NT 400 mg adheres to rigorous cGMP (current Good Manufacturing Practices) guidelines at Asitanila Remedies\' manufacturing partner’s certified manufacturing plants. · The synthesis and formulation processes are meticulously validated to ensure batch-to-batch consistency in drug content uniformity, dissolution characteristics, and overall product quality attributes. · Advanced pharmaceutical unit operations, including high-shear granulation, fluid-bed drying, and automated tablet compression, are employed under strict environmental controls (HVAC systems maintaining specified temperature and humidity). Packaging for Enhanced Therapeutic Utility: · ASITAGAB NT 400 mg tablets are primarily packaged in ALU-ALU packs , providing a superior barrier against moisture permeation and photodegradation, thereby ensuring the chemical stability and extending the shelf life of the active pharmaceutical ingredients . · The packaging design prioritizes unit dose integrity, minimizing the risk of contamination and ensuring the correct dosage is administered. Pharmacotherapeutic Advantages for the Medical Fraternity: The combination leverages the distinct yet complementary mechanisms of action of Gabapentin (modulation of α2δ subunit of voltage-gated calcium channels) and Nortriptyline (inhibition of norepinephrine and serotonin reuptake). This rational polypharmacy can result in enhanced analgesic efficacy in complex neuropathic pain states, potentially achieving superior pain relief compared to individual monotherapies. · Improved Medication Adherence Potential: The fixed-dose combination simplifies the therapeutic regimen, potentially reducing the pill burden and enhancing patient compliance, which is crucial for optimal chronic pain management outcomes. Clinical Benefits for Patients: · Augmented Analgesic Efficacy: The synergistic interaction of Gabapentin and Nortriptyline can lead to more effective pain reduction in debilitating neuropathic pain syndromes, improving functional capacity and overall well-being. · Potential for Dose Optimization and Reduced Side Effects: In some patients, the combination may allow for the use of lower doses of each individual component while achieving comparable or superior analgesia, potentially mitigating dose-dependent adverse effects associated with higher doses of either agent alone. · Enhanced Quality of Life: Effective management of chronic neuropathic pain with ASITAGAB NT 400 mg can translate to improvements in sleep patterns, mood, and daily activities, significantly enhancing the patient\'s quality of life. · Simplified Treatment Regimen: The convenience of a single tablet formulation can improve adherence, leading to more consistent therapeutic drug levels and potentially better long-term pain control.