E. Y. Vouffo, R. Temdie, M. M. Donfack, M. G. K. Minoue, B.G.A. Azebaze, A. Dongmo, T. Dimo
{"title":"Hepatoprotective effects of Allanblackia gabonensis aqueous trunk bark extract on carbon tetrachloride-induced chronic liver damage in Wistar rats","authors":"E. Y. Vouffo, R. Temdie, M. M. Donfack, M. G. K. Minoue, B.G.A. Azebaze, A. Dongmo, T. Dimo","doi":"10.25259/ajpps_2023_007","DOIUrl":"https://doi.org/10.25259/ajpps_2023_007","url":null,"abstract":"\u0000\u0000Natural bioactive compounds protect against oxidative stress-induced diseases. Studies have demonstrated antioxidant properties of Allanblackia gabonensis (member of Clusiaceae family), which is used for liver diseases. This work was designed to investigate the hepatoprotective effects of A. gabonensis aqueous trunk bark extract against carbon tetrachloride (CCl4)-induced chronic liver injury.\u0000\u0000\u0000\u0000Rats were divided into six groups of five rats each. Rats of control and CCl4 groups received distilled water orally from week 1 to week 12. A. gabonensis aqueous extract was given orally to preventive (PREV) test group (200 mg/kg) from week 1 to week 12. SIM group and two curative groups received silymarin 25 mg/kg and extract (100 or 200 mg/kg) from week 8 to week 12. CCl4 was injected hypodermically to induce chronic liver injury to all groups except control, 2 h after treatment, from week 1 to week 12. All rats were often weighed and were sacrificed 12 weeks later under anesthesia and blood was collected in ethylene diamine tetra-acetic acid tubes and plain tubes for hematological profiling and serum preparation, respectively. Liver and kidney functions were assessed by measuring alanine transaminase (ALT), aspartate aminotransferase (AST) serum activities, serum creatinine, total bilirubin, and total protein levels. Superoxide dismutase (SOD), catalase, glutathione (GSH), and malondialdehyde (MDA) were assessed. Histology of the liver and kidney was done.\u0000\u0000\u0000\u0000Administration of CCl4 to rats resulted in significant (P < 0.05) impairment of the animals’ weight growth. ALT activity, creatinine, total bilirubin, and MDA levels were significantly increased. Total proteins, GSH levels, SOD, and catalase activities were decreased in the CCl4 group compared to control. PREV or curative administration of A. gabonensis extract (100 or 200 mg/kg) significantly reduced liver injury by preventing significant elevation of ALT activity, creatinine, and total bilirubin levels and exhibited significant reduction in the levels of MDA, compared to the CCl4-group. These effects of A. gabonensis extract were evident by a marked improvement of the liver and kidney histological architectures.\u0000\u0000\u0000\u0000The results revealed antioxidant and anti-inflammatory hepatoprotective effects of the aqueous extract of A. gabonensis and constituted a scientific basis for further research on this plant.\u0000","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130127125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Droxidopa for refractory neurogenic orthostatic hypotension in amyloid light chain amyloidosis","authors":"Hien Ha, N. L. Nguyen","doi":"10.25259/ajpps_2023_006","DOIUrl":"https://doi.org/10.25259/ajpps_2023_006","url":null,"abstract":"Neurogenic orthostatic hypotension (nOH) secondary to amyloidosis is a rare condition associated with significant blood pressure (BP) drops and problematic symptoms for patients. There is limited literature on the management of nOH secondary to amyloidosis. In this report, we describe a case on a 60-year-old female with an extensive past medical history, including amyloidosis, pulmonary hypertension, heart failure with preserved ejection fraction, and episodic hypotension, who presents to the hospital with dizziness and home systolic BP readings in the 80s. Due to hypoperfusion, she eventually developed acute kidney failure and was transferred to the intensive care unit (ICU) for intermittent continuous renal replacement therapy with pressor support using norepinephrine. She had difficulty maintaining adequate BPs while on midodrine, so fludrocortisone, followed by pseudoephedrine, were added to improve her pressures. She was subsequently transferred out of the ICU, but her BPs still remained low, and she was not able to sit up without getting dizzy. Droxidopa was eventually added on to help treat her refractory nOH. After droxidopa initiation, her BPs improved and she was able to sit up without dizziness and was finally discharged home. This case report demonstrates the therapeutic usefulness of droxidopa in improving both BPs and symptoms in refractory nOH secondary to amyloidosis.","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"65 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131907737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Chinaeke, Ismaeel Yunusa, B. Love, J. Magagnoli, C. E. Reeder
{"title":"Intensive care unit mortality and length of stay among critically ill patients with sepsis treated with corticosteroids: A retrospective cohort study","authors":"E. Chinaeke, Ismaeel Yunusa, B. Love, J. Magagnoli, C. E. Reeder","doi":"10.25259/ajpps_2023_005","DOIUrl":"https://doi.org/10.25259/ajpps_2023_005","url":null,"abstract":"\u0000\u0000Sepsis is a major cause of morbidity and mortality in critically ill patients worldwide, and corticosteroids are commonly used to treat it. However, the evidence supporting the use of corticosteroids in sepsis patients admitted to the intensive care unit (ICU) is of low certainty, with conflicting results reported in previous studies. Thus, we aimed to investigate the potential association between corticosteroid treatment and various outcomes, including 30-day ICU mortality, ICU length of stay (LOS), mechanical ventilation use, new onset of infection, and hyperglycemia in patients diagnosed with sepsis and admitted to the ICU.\u0000\u0000\u0000\u0000We conducted a cohort study utilizing data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database from 2008 to 2019. The study compared users of corticosteroids following admission to the ICU with non-users. Outcomes assessed included 30-day ICU mortality, ICU length of stay (LOS), mechanical ventilation use, new onset of infection, and hyperglycemia. Doubly robust, augmented inverse propensity weighted models were employed to control for confounders and determine the average treatment effect (ATE) of corticosteroids on study outcomes.\u0000\u0000\u0000\u0000A total of 10,098 patients with a first diagnosis of sepsis were identified, of which 1,235 (12.2%) received corticosteroid treatment, and 8,863 (87.8%) did not. Corticosteroid use was associated with increased 30-day ICU mortality (ATE, 0.127; 95% CI, 0.083 to 0.171), ICU LOS (ATE, 1.773; 95% CI, 1.036 to 2.510), mechanical ventilation use (ATE, 0.181; 95% CI, 0.130 to 0.233), new onset of infection (ATE, 0.063; 95% CI, 0.032 to 0.094), and hyperglycemia (ATE, 0.024; 95% CI, 0.013 to 0.035) compared to non-use.\u0000\u0000\u0000\u0000The safety profile of corticosteroid therapy in sepsis patients admitted to the ICU remains a concern. Clinicians should carefully consider all available evidence and patient preferences when deciding to prescribe corticosteroids. Given the low certainty of evidence supporting the current treatment guidelines, further research is warranted to provide a more conclusive understanding of the risks and benefits associated with corticosteroid use in this patient population.\u0000","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131400648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
U. Eze, M. Eze, Chinonyerem O. Iheanacho, Samuel Agim Abuh, P. Igbinaduwa
{"title":"Point of care testing and health parameter assessment in community pharmacy setting","authors":"U. Eze, M. Eze, Chinonyerem O. Iheanacho, Samuel Agim Abuh, P. Igbinaduwa","doi":"10.25259/ajpps_2023_003","DOIUrl":"https://doi.org/10.25259/ajpps_2023_003","url":null,"abstract":"\u0000\u0000Health screening is essential for early detection and prompt management of diseases, particularly chronic conditions. The study assessed and classified participants’ health parameters according to standard classifications. Associations between participants’ socio-demographics and observed health parameters were also assessed.\u0000\u0000\u0000\u0000A cross-sectional survey of 400 adults was performed in a community pharmacy in Nigeria, using a pretested questionnaire. Health parameters were measured and analyzed descriptively with SPSS version 24. Chi-square tests and Pearson’s correlation analysis were also performed (P < 0.05).\u0000\u0000\u0000\u0000A 100% response rate was recorded in the study. Mean temporal temperature (TT) and respiratory rate (RR)/minute were 36.627°C ± 0.3143 and 18.20 ± 3.261, respectively. Almost half, (195; 48.8%) were 20–39-years-old. Almost all (399/400; 99.8%) had normal TT, normal RR (347/400; 86.8%), fasting blood glucose (FBG) (326/400; 81.5%), and about a third had pains (156/400; 39.0%). Age was significantly associated with RR (P = 0.008) and FBG (P = 0.002). Gender and educational levels were significantly associated with RR (P = 0.003) and FBG (P = 0.001), respectively. A weak negative correlation (r = −0.018; P = 0713) between participants’ FBG and TT was observed. FBG was negatively correlated with pain level (r = −0.091; P = 0.068), while pain level was negatively correlated with TT (r = −0.010; P = 0.832). Relationship between TT and RR showed weak positive correlation (r = 0.023; P = 0.637).\u0000\u0000\u0000\u0000Health parameters were mostly normal, but selectively associated with socio-demographics. The study shows the role of community pharmacists in routine point of care testings, and findings suggest a focus of healthcare on the correlation of age, gender and educational level with FBG and RR.\u0000","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117325101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Z. Yahaya, Lisha Giwa, Charles Na’anman Dagogot, O. Orugun, O. Adeleye, B. Mohammed
{"title":"Evaluation of the suspending properties of Parkia biglobosa mucilage in a metronidazole suspension formulation","authors":"Z. Yahaya, Lisha Giwa, Charles Na’anman Dagogot, O. Orugun, O. Adeleye, B. Mohammed","doi":"10.25259/ajpps_2023_004","DOIUrl":"https://doi.org/10.25259/ajpps_2023_004","url":null,"abstract":"\u0000\u0000The aim of this work is to assess the suitability of Parkia biglobosa mucilage (PBM) as a suspending agent in metronidazole suspension.\u0000\u0000\u0000\u0000Metronidazole suspension was formulated with mucilage (0.1%, 0.5%, 1%, and 2% w/v) from P. biglobosa seeds as the suspending agent. Similar suspensions of metronidazole that contained (0.1%, 0.5%, 1%, and 2% w/v) tragacanth or gelatin were also prepared for comparison to PBM-based formulations. The suspensions were assessed for rheological properties, sedimentation volume, degree of flocculation, ease of redispersion, flow rate (flowability), and drug-excipient compatibility using Fourier-transform infrared spectroscopy.\u0000\u0000\u0000\u0000Brownish metronidazole suspensions with a smooth and elegant appearance were obtained. After 2 weeks of storage at ambient temperature (28 ± 2°C), the ease of redispersion was in the following order: tragacanth < PBM < gelatin-containing formulations. The optimal pH of the formulation was slightly acidic and did not significantly change (p > 0.05) after 3 months of storage at ambient temperature (28 ± 2°C). However, the viscosity of the formulations was reduced by more than 30%, and the flow rate was significantly increased (P < 0.05). Suspensions formulated with 2% PBM were well-flocculated and easily redispersible. Furthermore, the sedimentation volume and sedimentation rate of suspensions formulated with 2% PBM were comparable to that of tragacanth- and gelatin-containing suspensions.\u0000\u0000\u0000\u0000PBM hence has great promise as a suspending agent for pharmaceutical preparations.\u0000","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125516269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Congenital hyperinsulinism in a Nigerian infant: A case report and review of literature","authors":"I. Yarhere, T. Jaja","doi":"10.25259/ajpps_2023_002","DOIUrl":"https://doi.org/10.25259/ajpps_2023_002","url":null,"abstract":"Congenital hyperinsulinism, a rare genetic disorder characterized by excess insulin secretion even during hypoglycemic episodes, has two histological subtypes; diffuse and focal. Genotypes denote which of the two subtypes presents, and this is the first case being reported in Nigeria. The aims of this study were to report the first case of genetically confirmed compound heterozygote inheritance for two non-sense mutations in the ABCC8 gene in a Nigerian child and her family. A full-term average weight (7.5 lb) female baby presented with severe hyperinsulinemic hypoglycemia [HH] after birth and failed medical treatment with dextrose infusion. She had several hypoglycemic seizure episodes and spastic diplegic cerebral palsy, despite frequent feeding. Following physiotherapy, her spasticity was regressing and she was also able to say polysyllabic words. Genetic testing done 2 years after birth showed that her father was heterozygous for the ABCC8 non-sense mutation, P.W143*, and her mother was heterozygous for the P.Q416* ABCC8 mutation. This report shows the need for quick and early genetic testing for rare disorders and the possibility of collaboration with more specialized genetic laboratories. When diagnosed, diffuse or focal diazoxide unresponsive hypoglycemia may be treated by partial or complete pancreatectomy with the potential complication of diabetes mellitus later in life.","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"24 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120858891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Obi, Anthony C. Ikeme, P. Nwakama, Ashiwel S. Undieh
{"title":"The Calabar bean and physostigmine: from African ethno-jurisprudence to medicinal discovery and modern pharmacotherapeutics","authors":"J. Obi, Anthony C. Ikeme, P. Nwakama, Ashiwel S. Undieh","doi":"10.25259/ajpps_2023_001","DOIUrl":"https://doi.org/10.25259/ajpps_2023_001","url":null,"abstract":"Physostigmine, or eserine, is an alkaloid found in the Calabar bean (eséré), Physostigma venenosum (Balfour). The scientific discovery of physostigmine played a pivotal role in our understanding of chemical neurotransmission and the emergence of pharmacology as a science. The Efik people of Old Calabar, in present day Cross River State of Nigeria, used the bean as an ordeal poison to determine if persons accused of certain allegations such as witchcraft were guilty or innocent. Scottish missionaries working in Old Calabar witnessed eséré ordeal trials and attended to patients inadvertently poisoned by the plant. Perplexed by the ordeal trials and concerned for their patients, the missionaries sent reports of their observations and samples of the beans to scientists back in Britain for study. Evaluations of the plant material for its chemical constituents and biological activity led to the discovery of its active principle, physostigmine. Further explorations with physostigmine led to the discovery of acetylcholine and chemical neurotransmission, and the Nobel Prize for Physiology or Medicine in 1936. From a classic practice of ethno-jurisprudence, the world came to understand the chemical basis of synaptic transmission, and the nature of substrate-enzyme and ligand-receptor interactions as underlying principles in biochemistry and pharmacology. Numerous medicines including physostigmine have been developed based on these principles and are being used in current pharmacotherapy. The rich history of eséré plant and its physostigmine alkaloid anchors a compelling story of the role natural products have played in the discovery of modern therapeutic agents. Moreover, the story highlights the reality that probably many more medicinal plants in Africa remain to be explored for their chemical constituents as potential leads in breakthrough drug discovery.","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127606798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Timothy S. Daly, Zarian Prenatt, H. Sagin, Sally Wen, K. Shah, Subhash Proothi, Prabhdeep Hehar
{"title":"A case of acute hyperammonemic encephalopathy after initiation of 5-fluorouracil chemotherapy","authors":"Timothy S. Daly, Zarian Prenatt, H. Sagin, Sally Wen, K. Shah, Subhash Proothi, Prabhdeep Hehar","doi":"10.25259/ajpps_16_2022","DOIUrl":"https://doi.org/10.25259/ajpps_16_2022","url":null,"abstract":"5-fluorouracil is a chemotherapeutic agent that has been used for decades to treat a number of neoplasms. It has a number of adverse effects; however, we present a case of a seldom reported side effect in hyperammonemic encephalopathy that should be considered in patients presenting with altered mental status shortly after starting therapy.","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132540025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Timothy S. Daly, Karla Ramos-Feliciano, Matthew Titus, Osamudiamen Idahosa, Jonathan Trager, J. Axelband
{"title":"Primary pyogenic ventriculitis caused by Streptococcus intermedius","authors":"Timothy S. Daly, Karla Ramos-Feliciano, Matthew Titus, Osamudiamen Idahosa, Jonathan Trager, J. Axelband","doi":"10.25259/ajpps_17_2022","DOIUrl":"https://doi.org/10.25259/ajpps_17_2022","url":null,"abstract":"Pyogenic ventriculitis is a rare infection especially when it occurs without any prior central nervous system instrumentation. We present a case of severe Streptococcus intermedius ventriculitis in an immunocompetent host.","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"99 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127094707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. C. Chun, P. Nwakama, Devvrat T. Patel, Ke Ren, A. Braddy
{"title":"Reconciling sprinkle administration information in approved NDA labeling with sprinkle bioequivalence study recommendations in FDA product-specific guidances for generic drug development","authors":"S. C. Chun, P. Nwakama, Devvrat T. Patel, Ke Ren, A. Braddy","doi":"10.25259/ajpps_18_2022","DOIUrl":"https://doi.org/10.25259/ajpps_18_2022","url":null,"abstract":"\u0000\u0000Certain patient populations (e.g., children and the elderly) may not be able to swallow solid oral dosage forms. In the absence of availability of a dosage form that is appropriate for these patient groups, liquids and/ or soft foods as described in the Food and Drug Administration (FDA)-approved product labeling can be used as a suitable vehicle(s) for oral administration of the specific drug product. The approved labeling of some new drug application (NDA) products contains information for sprinkle administration on liquids or soft foods. Since abbreviated new drug application (ANDA) products must demonstrate bioequivalence (BE) to the reference listed drug (RLD) products, and since the generic drug labeling is the same as RLD, generic applicants are recommended to conduct in vivo BE sprinkle study using one of the soft foods mentioned in RLD labeling. The current FDA guidance specifically recommends that generic applicants conduct a sprinkle BE study if the labeling of a modified-release (MR) RLD product states that the product can be administered sprinkled on soft foods. For ANDAs, such recommendations for in vivo BE sprinkle studies for MR products are routinely communicated in the respective product-specific guidance (PSG) published by FDA and readily available for prospective ANDA applicants. FDA guidance does not recommend sprinkle BE study for an immediate-release (IR) product since the formulation differences between IR generic and RLD products are not expected to impact administration with food vehicle.\u0000\u0000\u0000\u0000FDALabel and PSG databases were searched for current NDAs with sprinkle labeling and individual PSGs with recommendations for an in vivo sprinkle BE study, respectively. Results from FDALabel were narrowed to NDAs for oral solid dosage forms with approved labeling for sprinkle administration on food vehicles. Only MR NDAs with sprinkle labeling were included in the final analysis as recommended by FDA for inclusion of in vivo sprinkle BE study recommendations in PSGs for generic products. We searched the FDA external PSG database for availability of respective PSGs containing in vivo sprinkle study recommendations for those MR products with approved NDA labeling for sprinkle administration.\u0000\u0000\u0000\u0000Of the 57 NDAs with FDA-approved drug products that are labeled to include sprinkle administration, 45 NDAs were MR (tablet, capsule, and granule) products. Forty-two (93%) of the 45 MR products have PSGs with in vivo sprinkle BE study recommendations. Standardized data extraction sheets created by Microsoft Excel 2019 for data extraction were utilized.\u0000\u0000\u0000\u0000FDA has a sprinkle-study PSG for almost all currently approved MR NDAs. The results of our study show that in vivo BE study recommendations in PSGs closely match information in the approved drug labeling. Applicants who plan to develop MR generic products should visit the FDA public web page for the availability of the product-specific BE recommendations for the proposed products.\u0000","PeriodicalId":376259,"journal":{"name":"American Journal of Pharmacotherapy and Pharmaceutical Sciences","volume":"24 4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114106632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}