Background: Recurring international recalls of essential oral solid dosage forms contaminated with Nitrosamine Drug Substance-Related Impurities (NDSRIs) expose a fundamental vulnerability in conventional tablet manufacturing. Trace inorganic nitrites (0.1–10.0 µg/g) present across widely used excipients like crospovidone and microcrystalline cellulose react directly with vulnerable secondary amine drugs during standard processing and routine shelf storage. Objective: Here, we developed an economically practical, scalable formulation strategy to suppress excipient-mediated nitrosamine formation using food-grade antioxidant scavengers, paired with an accessible isocratic reverse-phase high-performance liquid chromatography (RP-HPLC-UV) analytical control method validated strictly against ICH Q2(R2) and ICH Q14 requirements. Methods: Propranolol hydrochloride served as a representative aliphatic secondary amine (pKa = 9.45). Direct-compression binary powder mixtures were spiked with 5.0 µg/g sodium nitrite at microenvironmental pH 3.0, then incubated under accelerated thermal stress (60.0°C ± 1.0°C for 48 hours). We tested the protective capacity of L-ascorbic acid (0.1% and 0.5% w/w) against L-histidine (0.5% w/w). Chromatographic resolution was carried out on an Inertsil ODS-3V C18 column (250 × 4.6 mm, 5 µm) using an isocratic mobile phase of acetonitrile and 25 mM potassium phosphate buffer (pH 3.00 ± 0.05) (55:45, v/v) at 1.0 mL/min with photodiode array detection at 290 nm. Results: Positive control blends generated substantial quantities of N-nitroso-propranolol (NNP; mean peak area 142,580 ± 1,820 mAU·s). Incorporating 0.5% w/w L-ascorbic acid suppressed NNP formation by 98.70% ± 0.06% (p < 0.0001), while 0.5% w/w L-histidine yielded 92.30% ± 0.16% inhibition. Our chromatographic assay satisfied every ICH Q2(R2) requirement: linearity spanned 10.0–150.0 µg/mL (R² = 0.9996), system repeatability remained tight at 0.68% RSD, recovery ranged between 99.12% and 100.82%, with limits of detection and quantification established at 0.42 µg/mL and 1.28 µg/mL, respectively. During 6-month accelerated stability testing (40°C ± 2°C / 75% ± 5% RH), finished tablets retained NNP levels at 0.28 ppm (44.8 ng/day daily intake), leaving a 33.5-fold safety margin below the US FDA limit of 1500 ng/day. Conclusion: Blending 0.5% w/w ascorbic acid offers an accessible, zero-cost-penalty platform that halts mutagenic nitrosation well below global regulatory thresholds, without disturbing tablet hardness, disintegration, or dissolution behavior.
The basic physiology of the menstrual cycle is a complex mechanism. This involves sequence of phases in coordination with the hypothalamus, anterior pituitary, ovary and endometrium. Normalcy and rhythmic menstruation are prime factors fornormal reproduction. The menstrual cycle with all its complexities can be easily perturbed and lead to Oligomenorrhoea and Hypomenorrhea, the most common conditions seen in the present era. Its prevalence from different studies is 13.5 and 12.95 respectively. In classics, based on the pathophysiology of Lakshana by considering Dosha, Dushya, Agni, Srotas etc. this condition can be considered as Artava Kshaya. It is Agnimandhyajanya Vikara having Bahudoshavastha with Kapha Vata Dushti where Kapha produces Avarana to Vata Dosha and obstructs Artava Vaha Srotas. So, Deepana Pachana, Shodhana followed with Shamana Chikitsa corrects the pathophysiology Artava Kshaya.
Monoclonal antibodies (mAbs) are increasingly being prescribed to patients and investigated in the field of medicine and research. This class of medication is unique due to its ability to be engineered into targeting a specific receptor. Numerous studies and reviews have reported the efficacy, potency, and clinical usage of mAbs in the treatment of a variety of diseases ranging from autoimmune disorders to malignant cancers. However, very few publications classify and provide a brief synopsis of mAbs that includes their pharmacological profiles. mechanisms of action, uses, and side effects in a concise manner. Therefore, this review aims to classify the current mAbs drugs used in clinical practice according to system diseases by providing a brief summary for each of them. For example, regarding cardiovascular disorders, mAbs such as Abciximab, Bevacizumab, and Digoxin Immune Fab will be reviewed. Denosumab, used to treat musculoskeletal disorders, will be also discussed. In addition, mAbs such as Adalimumab, Eculizumab, Natalizumab used in autoimmune disorders and Alemtuzumab, Trastuzumab, Cetuximab, and Rituximab that are prescribed for tumors will be reviewed. Finally, we shall discuss two mAbs that are IL-6 antagonists, Tocilizumab and Siltuximab, which are in ongoing clinical trials as potential treatments of COVID-19. The mAbs have profound benefits against chronic and malignant conditions, and the overall purpose of this review is to illustrate the basic pharmacological profiles of mAbs that physicians may find useful in establishing their management protocols.
Aim: The main objective of the present work is formulate and optimizes the combination anti-allergic tablet of Cetirizine and curcumin. Rosemary extract is used to enhance the therapeutic effect in both acute and chronic cases. Material and Method: The Antiallergic tablet is formulate by the wet granulation method using various excipients like HPMC, lactose starch, Polyethylene glycol in different concentrations for optimization of excipients. Rosemary extract contains ursolic acid and rosmarinic acid. Which is shows antiinflammatory and Antiallergic activity so that it is used in the combination of Cetirizine and curcumin. Result and Discussion: FTIR spectra of API and combined with excipients showed no change in the peak indicating the absence of interaction, The prepared formulation evaluated for Precompresion studies such as bulk density, tapped density, carr’s index, Hausner’s ratio and angle of repose. The post-compression studies such as weight variation, disintegration, dissolution, uniformity of drug content, general appearance, friability, and hardness. All the prepared formulation was within the standard pharmacopoeial limits. Prepared formulation shows the Maximum Drug release of cetirizine is 78.90% and curcumin is 87.35% in a 14 minute of dissolution study. Conclusion: After studied we conclude that formulation is compatible with excipients and stable at 40 0 c for 3 months and it shows better drug release profile.
