scholarly journals Analisis Penyebab dan Solusi Rekonsiliasi Finished Goods Menggunakan Hipotesis Statistik dengan Metode Pengujian Independent Sample T-Test di PT.Merck, Tbk.

Jurnal Tekno ◽  
2019 ◽  
Vol 16 (2) ◽  
pp. 35-48
Author(s):  
Riana Magdalena ◽  
Maria Angela Krisanti
Keyword(s):  
T Test ◽  
Over The Counter ◽  
Coated Tablet ◽  
Core Tablet

Merck, Tbk. merupakan perusahaan manufaktur yang bergerak di bidang pembuatan obat dengan memproduksi obat yang dituju untuk pasar over-the-counter (OTC) seperti Sangobion dan Neurobion dan juga pasar obat resep untuk rumah sakit. Berdasarkan Packaging Work Sheet (PWS) dari produk “X” yang diproduksi di PT. Merck, Tbk. ditemukan rekonsiliasi pada finished goods yang melebihi spesifikasi yang telah ditentukan sebelumnya oleh perusahaan. Rekonsiliasi merupakan perbedaan antara jumlah material yang masuk dengan material yang keluar sehingga jika rekonsiliasi melebihi yang seharusnya maka PT. Merck, Tbk. dapat mengalami kerugian karena jumlah material yang jadi tidak sesuai dengan material yang diproduksi. Berdasarkan permasalahan yang terjadi, maka penulis melakukan pengolahan data menggunakan hipotesis statistik dengan menggunakan metode pengujian Independent Sample T-Test untuk mengetahui proses produksi apa yang berpotensi menyebabkan rekonsiliasi pada finished goods produk “X”. Dengan diketahuinya penyebab dari rekonsiliasi maka dapat dicari solusi yang tepat untuk mengatasi rekonsiliasi tersebut. Dari pengolahan data yang dilakukan, ditemukan bahwa terdapat perbedaan secara nyata antara berat rata-rata core tablet dengan berat coated tablet yang menandakan bahwa proses sugar coating berpengaruh secara signifikan terhadap variasi berat yang berpotensi menyebabkan rekonsiliasi. Oleh karena itu, ditentukan solusi yang tepat untuk memperbaiki proses tersebut.

scholarly journals FORMULATION AND IN VITRO–IN VIVO PHARMACOKINETIC EVALUATION OF CARDIOVASCULAR DRUG-LOADED PULSATILE DRUG DELIVERY SYSTEMS

2021 ◽  
pp. 144-151
Author(s):  
KUMAR BABU PASUPULETI ◽  
VENKATACHALAM A. ◽  
BHASKAR REDDY KESAVAN
Keyword(s):  
Drug Release ◽  
Ethyl Cellulose ◽  
Release Kinetic ◽  
In Vitro Drug Release ◽  
The Core ◽  
Coated Tablet ◽  
Tablet Formulations ◽  
Core Tablet

Objective: This study is to formulate Nebivolol into a Pulsatile liquid, solid composite compression coated tablet, which will delay the release of the drug in early morning hypertension conditions. Methods: The liquid, solid composite tablet was formulated and compressed with the ethylcellulose coating polymer. The percent in vitro drug release of the liquid solid composite compressed tablet was tested. Based on disintegration time and wetting time, the LCS2, LCS3, LSC6, LCS7 and LCS12 formulations were found to be the optimized solid-liquid compacts fast-dissolving core tablet formulations, which may be excellent candidates for further coating with polymer to transfer into press coated pulsatile tablet formulations. Coating the core tablet with varying ethyl cellulose concentrations resulted in five different formulations of the pulsatile press-coated tablet (CT1, CT2, CT3, CT4, CT5). In vitro drug release, in vitro release, kinetic studies, in vivo pharmacokinetic and stability tests were all performed for the prepared pulsatile press coated tablet. Results: CT3 tablets are coated with ethyl cellulose polymer, which shows maximum controlled drug release from the core tablet i.e. 96.34±1.2% at 8th h. It shows there was an efficient delay in drug release form core tablet i.e. up to 3 h, followed by the maximum amount of drug release of 96.34±2.4 at 8h. Which shows the core drug will be more efficiently protected from the gastric acid environment 1.2 pH, duodenal environment 4.0 pH and release drug only in the small intestine. Conclusion: According to the findings, CT3 Pulsatile press-coated tablet increased the bioavailability of Nebivolol by 3.11 percent.

scholarly journals Preparation and characterization of timed drug delivery system of sumatriptan using natural polymers

2018 ◽  
Vol 27 (1) ◽  
pp. 89-99
Author(s):  
Mina Shihab Al-anbagi ◽  
Nawal A. Rajab ◽  
Yehia I.Khalil
Keyword(s):  
Drug Delivery ◽  
Circadian Rhythm ◽  
Active Pharmaceutical Ingredient ◽  
Lag Time ◽  
Natural Polymers ◽  
The Press ◽  
Coated Tablet ◽  
Pulsatile Drug Delivery ◽  
Core Tablet

Pulsatile drug delivery systems are time-controlled dosage forms which are designed to release the active pharmaceutical ingredient after a predetermined lag time to synchronize the disease circadian rhythm. A migraine shows circadian rhythm with a marked increase in attacks between 6 a.m. and 8 a.m. Sumatriptan is a selective agonist at serotonin (5-Hydroxy tryptamine1  (5-HT1))receptors, is an effective treatment for acute migraine attacks. The aim of this work is to prepare time-controlled press-coated tablet with a lag time of 5.45 hrs. Six formulas of fast dissolving core tablets and three formulas of press-coated tablets were prepared by using direct compression method using different variables to prepare core tablets which include: different types and concentrations of superdisintegrants While different concentrations of natural and synthetic polymers were utilized in the preparation of press-coated tablets. The obtained results showed that formula  F4 of core tablet, which contained 25 mg of sumatriptan, 5% w/w sodium starch glycolate and avicel PH 102 as the diluent, was the selected formula that gave the fastest and complete release of sumatriptan. Also, formula C3 of the press-coated tablet, which contained pectin: EC100 mpa.s: HPMCK15M in concentration30mg: 10mg:160mg respectively, was selected as the best coating layer since it gave 5.45  hours lag time.

Effect of viscosity of hydrophilic coating polymer on lag time of atenolol pulsatile press coated tablets

2014 ◽  
Vol 1 (1) ◽  
pp. 15 ◽  
Author(s):  
Rajesh A Keraliya ◽  
Madhabhai M Patel
Keyword(s):  
Drug Delivery ◽  
Lag Time ◽  
Burst Release ◽  
Pulsatile Release ◽  
Hydrophilic Coating ◽  
Coated Tablet ◽  
Viscosity Grade ◽  
Pulsatile Drug Delivery ◽  
Pulsatile Delivery ◽  
Core Tablet

A method for the development of press coated tablet of atenolol for pulsatile delivery was investigated for chronotherapy of hypertension. Effect of viscosity of Hydroxypropylcellulose (HPC) on pulsatile release of atenlol was studied by press coating atenolol core tablet using different viscosity grade HPC and varying coat weight. L-HPC, M-HPC and H-HPC viscosity garde with 75, 100 and 150 mg coat weight were press coated over atenolol core tablets to delay release of atenolol. The batches, HP1-HP9, exhibited an increase in lag time in response to increase in viscosity and coat weight. Two of the batches HP5 and HP7 have shown a burst release of atenolol after 6.5 and 6.0 h lag time respectively, which is suitable for pulsatile drug delivery of atenolol for chronotherapy of hypertension.

scholarly journals Clinical Evaluation of the Whitening Effect of Over-the-Counter Dentifrices on Vital Teeth

2014 ◽  
Vol 25 (3) ◽  
pp. 203-206 ◽  
Author(s):  
Bruna Andrade Horn ◽  
Bruna Fortes Bittencourt ◽  
Osnara Maria Mongruel Gomes ◽  
Patrícia Almeida Farhat
Keyword(s):  
Clinical Trial ◽  
Standard Deviation ◽  
Randomized Clinical Trial ◽  
Clinical Evaluation ◽  
T Test ◽  
Over The Counter ◽  
Whitening Effect ◽  
Before And After ◽  
Color Alteration ◽  
One Way Anova

This randomized clinical trial evaluated the whitening potential of commercially available toothpastes. Sixty patients were selected and randomly divided into 4 groups (n=15), according to the dentifrice used: GI (control) - Colgate Total 12, GII - Close-up White Now, GIII: Oral-B 3D White, GIV: Colgate Luminous White. Three daily brushings were performed for 2 to 3 min each, during a period of 15 days. Patients had the color of their teeth evaluated before and after the treatment by means of a spectrophotometer (Vita EasyShade - CIE L*a*b*). Data obtained from L values were analyzed by one-way ANOVA and t test. ∆E was also evaluated to calculate color alteration, by NBS criteria. Mean (standard deviation) of initial values were GI: 82.9 (4.9); GII: 83.9 (5.8); GIII: 83.9 (7.2); GIV: 86.4 (3.4) and final values were GI: 84.1 (6.3); GII: 84.6 (6.1); GIII: 84.2 (7.1); GIV: 88.2 (2.8). In conclusion, the dentifrices showed no lightening action on vital teeth, except for Colgate Luminous White; but according to NBS criteria, there was no noticeable visible change to the patients in any group.

scholarly journals Long Term Conventional Bonds versus Long Term Sukuk Issuances and Their Determinants in Malaysia

2018 ◽  
Vol 2 (2) ◽  
pp. 17-25
Author(s):  
Noriza Mohd Saad ◽  
Keyword(s):  
Secondary Data ◽  
T Test ◽  
Secondary Market ◽  
Over The Counter ◽  
The Mean

Both instruments, either conventional bonds or sukuk (Islamic bonds) were trading under the same roof, in the secondary market and through over the counter in Malaysia. The main different is relying on sukuk trading shall be halal in transactions and fully compliant to shariah Islam but for conventional bonds is not restricted to this constituent. The objective of this study is to investigate the mean different between performance of sukuk and conventional bonds. Throughout, this study focused on the sample of 256 tranche of issuances consists of conventional bonds and sukuk with number of observations of 112 and 144 respectively. Secondary data is gathered from Bank Negara Malaysia (BNM) bond information Hub for fifteen conservative year’s period from 2000 to 2014. The methods of independent sample T-test and Levene’s test are employed in order to test the hypothesis. Interestingly, results revealed there is a significant mean different between long-term conventional bonds and sukuk performance denoting that these two debt instruments are performed in different ways even though trading in the similar marketplace.

scholarly journals Multilayer-Coated Tablet of Clopidogrel and Rosuvastatin: Preparation and In Vitro/In vivo Characterization

Pharmaceutics ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 313
Author(s):  
Ki-Soo Seo ◽  
Hyo-Kyung Han
Keyword(s):  
Plasma Concentration ◽  
Coating Layer ◽  
Maximum Plasma Concentration ◽  
Maximum Plasma ◽  
Dissolution Profile ◽  
Reference Drug ◽  
Acid Degradation ◽  
Glyceryl Behenate ◽  
Coated Tablet ◽  
Core Tablet

The acid lability of rosuvastatin hinders the preparation of mixed combination formulations of rosuvastatin with acidic drugs such as clopidogrel. Therefore, the purpose of this study was to develop a multilayer-coated tablet that avoids physicochemical interactions between rosuvastatin and clopidogrel. Among the tested hydrophobic materials, glyceryl behenate was most effective at inhibiting the production of lactone, the acid degradation product of rosuvastatin. Therefore, the multilayer-coated tablet included a hydrophobic separation layer consisting of glyceryl behenate between the clopidogrel core tablet and the rosuvastatin coating layer. In order to prevent delayed dissolution by the stable hydrophobic separation layer, crospovidone was added into the clopidogrel core tablet as an effective disintegrant. Copovidone was also added to the coating layer of rosuvastatin, achieving a dissolution profile comparable to that of the reference drug, Crestor®. The resulting multilayer-coated tablet exhibited similar pharmacokinetic profiles to those of reference drugs (Plavix® and Crestor®) in beagle dogs, and there was no statistically significant difference in the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (Tmax), or the area under the plasma-concentration time curve (AUC) between the test and reference formulations. The storage stability tests showed that the amounts of acid degradation products and total impurities were comparable to that of the reference drug. In conclusion, the present study successfully developed a stable multilayer-coated tablet containing both clopidogrel and rosuvastatin that may improve the patient compliance in combination therapy for cardiovascular diseases.

Acetaminophen: Neonatal hepatotoxicity due to late pregnancy exposure

1987 ◽  
Vol 45 ◽  
pp. 718-719
Author(s):  
G.A. Miranda ◽  
M.A. Arroyo ◽  
C.A. Lucio ◽  
M. Mongeotti ◽  
S.S. Poolsawat
Keyword(s):  
Low Dose ◽  
Fetal Liver ◽  
Late Pregnancy ◽  
Toxic Chemicals ◽  
Control Group ◽  
High Dose ◽  
Over The Counter ◽  
Liver And Kidney ◽  
Neonatal Liver ◽  
Childbearing Women

Exposure to drugs and toxic chemicals, during late pregnancy, is a common occurrence in childbearing women. Some studies have reported that more than 90% of pregnant women use at least 1 prescription; of this, 60% used more than one. Another study indicated that 80% of the consumed drugs were not prescribed, and of this figure, 95% were “over-the-counter” drugs. Acetaminophen, the safest of all over-the-counter drugs, has been reported to induce fetal liver necrosis in man and animals and to have abortifacient and embryocidal action in mice. This study examines the degree to which acetaminophen affects the neonatal liver and kidney, when a fatty diet is simultaneously fed to the mother during late pregnancy.Timed Swiss Webster female mice were gavaged during late pregnancy (days 16-19) with fat suspended acetaminophen at a high dose, HD = 84.50 mg/kg, and a low dose, LD = 42.25 mg/kg; a control group received fat alone.

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