Pulmonary Hypertension in Children with Ventricular Septal Defects.

BACKGROUND: Ventricular septal defect (VSD) is a common congenital heart disease which could be complicated with pulmonary hypertension (PH). OBJECTIVES: This study sought to establish the relationship between severity of PH and size of VSD and age. METHODS: This is a descriptive study where one hundred and fiftyone children aged 3 months to 18 years with echocardiographically confirmed VSD were studied. Pulmonary hypertension (PH) was determined using the tricuspid regurgitation jet velocity with a cutoff of systolic pulmonary arterial pressure (sPAP) at >25mmHg. Severity of pulmonary hypertension was classified into mild (25-50mg Hg); moderate, (51-60mm Hg) and severe ≥ 60mm Hg. Data were analysed using the SPSS version 25. RESULTS: Majority 52.9% had mild PH while 17.6% had severe PH. Mild PH (χ2=15.513, p=0.004) was found among 66.7% of those with small-sized VSD, 42% of those with moderate-sized VSD and 57.1% of those with large-sized VSD. There was a weak positive correlation between PH and size of VSD (n=132, r=0.320, p<0.001). For one-unit increase in age (in months), PH was noted to decrease by 0.030 (B= -0.030, 95%CI: -0.090- 0.030) and for a unit increase in size (mm) of VSD, PH increased by 1.681 units (B=1.681, 95%CI: 0.798- 2.563). CONCLUSION: There was a linear increase in pulmonary hypertension with increase in the size of ventricular-septal defect and decrease in the age of children with VSD. Age and VSD size were significant predictors of PH severity in children with VSD. All sizes of VSD are associated with pulmonary hypertension. A unit increase in age (in months), caused a decrease of PH by 0.030units and a unit increase in size (mm) of VSD resulted in an increased PH by 1.681 units.

CONTEXTE: La communication interventriculaire (CIP) est une cardiopathie congénitale courante qui peut se compliquer d'hypertension pulmonaire (HP). OBJECTIFS: Cette étude visait à établir la relation entre la sévérité de l'HTP et la taille de la communication interventriculaire et l'âge. MÉTHODES: Il s'agit d'une étude descriptive dans laquelle cent cinquante et un enfants âgés de 3 mois à 18 ans avec une VSD confirmée par échocardiographie ont été étudiés. L'hypertension pulmonaire (HP) a été déterminée en utilisant la vitesse du jet de régurgitation tricuspide avec un seuil de pression artérielle pulmonaire systolique (PAPS) à >25mmHg. La gravité de l'hypertension pulmonaire a été classée en légère (25-50mg Hg) ; modérée, (51-60mm Hg) et sévère ≥60mm Hg. Les données ont été analysées à l'aide du SPSS version 25. RÉSULTATS: La majorité 52,9% avait un PH léger tandis que 17,6% avaient un PH sévère. Un PH léger (χ2=15,513, p=0,004) a été trouvé chez 66,7% de ceux qui avaient une VSD de petite taille, 42% de ceux qui avaient une VSD de taille modérée et 57,1% de ceux qui avaient une VSD de grande taille. Il y avait une faible corrélation positive entre le PH et la taille de la VSD (n=132, r=0,320, p<0,001). Pour une augmentation d'une unité de l'âge (en mois), le PH a diminué de 0,030 (B= -0,030, 95%CI : -0,090- 0,030) et pour une augmentation d'une unité de la taille (mm) de la VSD, le PH a augmenté de 1,681 unités (B=1,681, 95%CI : 0,798- 2,563). CONCLUSION: Il y avait une augmentation linéaire de l'hypertension pulmonaire avec l'augmentation de la taille du défaut ventriculaireseptal et l'augmentation de l'âge des enfants avec VSD. L'âge et la taille de l'anomalie ventriculaire-septale étaient des prédicteurs significatifs de la gravité de l'hypertension pulmonaire chez les enfants atteints d'une anomalie ventriculaire-septale. Toutes les tailles de VSD sont associées à l'hypertension pulmonaire. Une augmentation unitaire de l'âge (en mois) a entraîné une diminution de l'HTP de 0,030 unité et une augmentation unitaire de la taille (mm) de la CIA a entraîné une augmentation de l'HTP de 1,681 unité. MOTS CLÉS: hypertension pulmonaire ; VSD ; taille ; âge.

Caring for Children with Congenital Heart Diseases:Economic Burden of Pre-Surgical Management on Nigerian Families.

BACKGROUND AND OBJECTIVES: Managing children with Congenital Heart Disease (CHD) attracts enormous cost especially in resource-poor settings like Nigeria. This study sought to determine the healthcare costs of pre-surgical management of CHD and describe its catastrophic effects on households. METHODS: Using a semi-structured interviewer-administered questionnaire, caregivers of children with CHD were interviewed. Family income, type of CHD, co-morbidity, healthcare payment mechanism and healthcare cost were explored over 3 months prior to the study. Healthcare costs were then averaged to obtain monthly estimates. Catastrophic health expenditure (CHE) was defined as healthcare spending above 10% family monthly income. Factors associated with increased healthcare spending in CHD management were explored using the Kruskal Wallis test of significance. RESULTS: Of the 108 parents interviewed, 81.0% paid for healthcare using out-of-pocket payment mechanism. The median direct monthly medical and non-medical costs were N==3,625 (range: N==200 - N==59,350) [$10.07; range:$0.56-$164.86] and N==420 (range: N==150 -N ==11,000) [$1.17; range $0.42-$30.56] respectively. Hospitalisation and transportation accounted for majority of the direct medical and non-medical costs, respectively. About 36.1% of families suffered financial catastrophe. Catastrophic overshoot and mean positive overshoot were 5.6% and 30.8% above the 10% income threshold, respectively. The healthcare spending was significantly higher in families of children with CHD complicated with heart failure (p=0.001) and pulmonary hypertension (p=0.038) and those who suffered financial catastrophe (p=0.001). Health insurance did not significantly reduce healthcare spending among the insured(p=0.630). CONCLUSION: The economic burden of pre-surgical management of children with CHD is high in Nigeria. Appropriate interventions governmental and non-governmental organisations are needed to cushion the burden of healthcare costs on affected families.

Attenuated Subcomponent Vaccine Design Targeting the SARS-CoV-2 Nucleocapsid Phosphoprotein RNA Binding Domain: In silico analysis

ABSTRACTThe novel coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has previously never been identified with humans, thereby creating devastation in public health. The need for an effective vaccine to curb this pandemic cannot be overemphasized. In view of this, we, therefore, designed a subcomponent antigenic peptide vaccine targeting the N-terminal (NT) and C-terminal (CT) RNA binding domains of nucleocapsid protein that aid in viral replication. Promising antigenic B-cells and T cell epitopes were predicted using computational pipelines. The peptides “RIRGGDGKMKDL” and “AFGRRGPEQTQGNFG” were the B cell linear epitopes with good antigenic index and non-allergenic property. Two CD8+ and Three CD4+ T-cell epitopes were also selected considering their safe immunogenic profiling such as allergenicity, antigen level conservancy, antigenicity, peptide toxicity, and putative restrictions to a number of MHC-I and II alleles. With these selected epitopes, a non-allergenic chimeric peptide vaccine incapable of inducing a Type II hypersensitivity reaction was constructed. The molecular interaction between the toll-like receptor-5 (TLR5) which was triggered by the vaccine was analyzed by molecular docking and scrutinized using dynamics simulation. Finally, in silico cloning was performed to ensure the expression and translation efficiency of the vaccine, utilizing pET-28a vector. This research, therefore, provides a guide for experimental investigation and validation.Competing Interest StatementThe authors have declared no competing interest.View Full Text

Neonatal outcomes associated with maternal recto-vaginal colonization with extended-spectrum ß-lactamase producing Enterobacteriaceae in Nigeria: a prospective, cross-sectional study.

OBJECTIVES: The objective of this study was to assess the prevalence of maternal recto-vaginal extended-spectrum ß-lactamase producing Enterobacteriacea (ESBL-E) colonization, identify risk factors for maternal and neonatal ESBL-E colonization, and subsequent impact on neonatal mortality. METHODS: A prospective, cross-sectional study was conducted at the University of Abuja Teaching Hospital from April 2016 to May 2017. Maternal-neonatal pairs were screened for ESBL-E exposure at time of delivery. Neonatal mortality was assessed at 28 days. RESULTS: A total of 1161 singleton deliveries were evaluated. In total, 9.7% (113/1161) of mothers and 4.3% (50/1161) of infants had ESBL-E-positive cultures at delivery. Maternal antibiotic exposure was associated with ESBL-E recto-vaginal colonization (18.6% (21/113) vs. 8.4% (88/1048), p < 0.001)). Maternal ESBL-E colonization (adjusted odds ratio (AOR) 14.85; 95% CI 7.83-28.15) and vaginal delivery (AOR 6.35; 95% CI 2.63-17.1) were identified as a risk factor for positive ESBL-E neonatal surface cultures. Neonatal positive ESBL-E surface cultures were a risk factor for neonatal mortality (stillbirths included, AOR 4.84; 95% CI 1.44-16.31). The finding that maternal ESBL-E recto-vaginal colonization appeared protective in regards to neonatal mortality (AOR 0.22; 95% CI .06-0.75) requires further evaluation. CONCLUSIONS: Maternal ESBL-E recto-vaginal colonization is an independent risk factor for neonatal ESBL-E colonization and neonates with positive ESBL-E surface cultures were identified as having increased risk of neonatal mortality.

Establishment of an erythropoietin CRS with stable measurable dimer content for SEC system suitability qualification

The European Pharmacopoeia (Ph. Eur.) monograph 1316 'Erythropoietin concentrated solution' prescribes that the dimer content of therapeutic erythropoietin (EPO) preparations must not exceed 2% as determined by Size-Exclusion Chromatography (SEC). This report describes the evaluation of a candidate Chemical Reference Substance (cCRS) to serve as system suitability reference material for the qualification of SEC systems used to assess dimer and oligomer content in EPO solutions. The study organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) was performed with the participation of six European laboratories which tested the candidate material and the EPO for physicochemical tests CRS batch 1. The candidate material was shown to be a suitable reference material for the determination of the resolving capability of the SEC system for separation of dimer and higher oligomers from monomeric EPO. The cCRS was adopted by the Ph. Eur. Commission as Erythropoietin for SEC system suitability CRS batch 1 following consideration of the report. The importance of the resolving capability of the SEC system, as defined by the peak ratios or the peak-to-valley resolution, together with the asymmetry of the peaks eluted, and the linear response of the UV detector were all seen as critical parameters. Therefore, the monograph Erythropoietin concentrated solution (1316) was revised concomitantly to take account of the CRS and to set acceptance criteria for these critical parameters..

Neonatal care - what do mothers in a rural Nigerian community know and practice?

BACKGROUND: Nigeria ranks among developing countries with poor neonatal health indices. This underscores the need for households and healthcare providers to understand the concept of newborn care and react appropriately and timely too. OBJECTIVE: To determine the knowledge and practices of mothers in the Elele community regarding neonatal care. MATERIALS AND METHODS: This was a community-based descriptive cross sectional study of 380 mothers who had a neonate. Mothers were selected using a multistage sampling technique. Data were collected by interview using a semi-structured questionnaire (with closed and open ended questions) and analyzed using a statistical package for social sciences version 22.0. Chi-square test was used to identify statistically significant associations among antenatal care clinic (ANC) attendance cum place of delivery and neonatal care practices. RESULTS: Ninety one (23.9%) of respondents were aware of at least four out of nine danger signs, while all reported wrapping their babies within 10 minutes after birth. Duration less than six hours from birth to first bath, feeding with or discarding of colostrum and timing of first breastfeeding within the first hour of birth were significantly associated with ANC attendance (p = 0.000, p = 0.002 and p = 0.000 respectively). Duration less than six hours to first bath, umbilical cord care and feeding with or discarding of colostrum were significantly associated with health facility delivery (p = 0.043, p = 0.026 and p = 0.003 respectively). CONCLUSIONS: Inadequate knowledge of newborn care among mothers was found, while non-ANC attendance and non-health facility delivery were associated with inappropriate neonatal care practices. We recommend comprehensive behavior change interventions, to promote proper neonatal care practices.

Sexual behaviours and contraceptive use among female secondary school adolescents in a rural town in RiverS state, South-south Nigeria.

BACKGROUND: According to World Health Organization (WHO), adolescents are persons aged 10-19 years. They comprise nearly half of the world's population of about 7 billion and 85% of them live in developing countries. AIM: The aim of this study is to assess the sexual behaviours, practices and contraceptive use among secondary school adolescents in Elele, Rivers State, Nigeria. METHOD: A cross-sectional descriptive study of 300 in-school adolescents in a rural community in Rivers State, South-South Nigeria, selected using multi-stage random sampling technique. RESULTS: There was a high awareness of contraception among respondents, 235 (78.3%), with condom, 207 (88.1%), having the highest awareness. About forty-five percent of respondents, (134), in this survey have had their first sexual debut and 84.3% of this number was sexually active in the last six months preceding this survey. The mean, median and the modal age of first sexual debut were; 12.0 + 2.8, 12.6, and 12.4 years respectively with the youngest age of initiation of sexual activity being 5 years. About two-thirds of those sexually active have multiple sexual partners. Contraceptive use was statistically higher among the sexually active respondents, (74.3%), than the sample study population, (30.3%), (Χ2 = 65.08, p = 0.000). Condom use at their last sexual debut, (58.2%), was significantly higher than use in their first sexual debut (31.3%), (Χ2 = 16.17, p = 0.000). The most commonly used contraceptive method was condom, (81.7%). CoNCLUSION: High risk sexual behaviour and increased sexual activity was prevalent in this age group. Efforts to promote sexuality education and contraceptive awareness should be intensified.

Acquired ventricular septal defect: a rare sequel of blunt chest trauma in a 7-year-old boy.

Ventricular septal defect (VSD) is the most common congenital cardiac lesion encountered worldwide. Only very rarely is it acquired, and causation through blunt injury in a child is extremely rare. A previously healthy 7-year-old boy suffered blunt chest trauma while at play. He presented 11 days later with features of acute congestive cardiac failure. Two-dimensional echocardiographic examination revealed a mid-muscular VSD. The connection between the defect and the trauma was not initially appreciated. Facilities for required urgent open-heart surgery were not available. Cardiac failure was refractory to anti-failure therapy. His clinical condition steadily worsened, and he succumbed after 20 days on admission. We conclude that a diagnosis of traumatic VSD, though rare, should be considered in any previously well child presenting in acute congestive cardiac failure following blunt trauma to the chest. Any such patient should undergo careful echocardiographic evaluation. There is an urgent need for facilities for open-heart surgery to be more readily available and accessible in Nigeria.

Breastfeeding and Weaning Practices among Nigerian Women

Background: Infant feeding is an important determinant of child well­being. The practice of exclusive breastfeeding over the years is declining despite efforts at all levels to improve it; and with globalization there is concern of possible drift in the traditional weaning practices among Nigerian women. This study, therefore, seeks to determine the breastfeeding and weaning patterns among mothers attending two health facilities in the northern and southern parts of Nigerian.Materials and Methods: This was prospective cross­sectional study involving mothers seen in Paediatrics Outpatient and Child Immunization Clinics. This study involved two hospitals in northern and southern Nigeria respectively. Results: Two hundred breastfeeding mothers were recruited into this study. 75% of the mothers were in 25­40 years group and the majority of them (40.0%) commenced breastfeeding after 60 min of delivery. 83% of the mothers were aware of exclusive breastfeeding, but only 40.5% practiced it; their main reasons were that: Breastfeeding was not enough for the growth and development of the child (26.1%) and that breast­milk did not contain enough water; however most mothers' breasts fed for >12 months. About 44.5% of the mothers introduced complementary feeds between 4 and 6 months, and most complimentary meals (53.5%)were maize­based. 61½% of the mothers abruptly stopped breastfeeding, and the practice of separating the child from the home during weaning was reported in only 16% of the mothers.Conclusion: Exclusive breastfeeding is still unacceptably low among Nigerian women despite anincreased level of awareness

Knowledge; Attitude; and Perception of Teething Myths among Medical Doctors in Nigerian Hospitals

Background: Teething commences in children from the age of 6 to 8 months; however; it has been wrongly associated with systemic symptoms such as fever; diarrhea; vomiting by parents and health workers; this study hopes to determine the perception of doctors toward teething in Nigeria. Materials and Methods: This was cross-sectional descriptive study. Convince sampling technique was used to select 139 doctors who consented to participate in the study. Results: There were 116 males and 23 females with male to female ratio of 5:1. Fifty-nine (42.4%) of the subjects believed teething was associated with at least one symptom while 80 (57.6%) of them disagreed. Twenty-two (15.8%) of them got information on teething from their parents; 3 (2.2%) from their grand-parents; 61 (43.9%) was from school; 5 (3.6%) was from friends while 18 (12.9%); and 30 (21.6%) were from patients and their personal experiences; respectively. Seventy-nine (56.8%) did not believe in seeking for medical care for teething; while 60 (43.2%) believe in seeking for medical care for teething complaints. Ninety-six (69.1%) of the subjects will not prescribe any medication for teething; 18 (12.9%) prescribed paracetamol for teething; 10 (7.2%) prescribed antibiotics for teething; 8 (5.8%) prescribe teething powder; 3 (2.2%) prescribed teething ring; and 2 (1.4%) prescribe clean cloth usage and teething syrup; respectively. Thirty-eight (27.4%) believed teething remedies works; 99 (71.2%) of the subjects did not believed it works while 2 (1.4%) were not sure of its efficacy. Conclusion: Doctors still believe that teething is associated with systemic illnesses; therefore continuous medical education is of importance in ensuring the eradication of these myths

Awareness, ownership and utilization of insecticide treated nets in Abavo community of Delta State.

BACKGROUND: Despite free distribution of insecticide treated nets in Nigeria, the use it as a means of malaria prevention and control has not been fuIly embraced. AIM: The aim of this survey was to determine the level of awareness, ownership and utilization of insecticide treated nets among residents of Abavo community, Delta State Nigeria METHOD: It is a descriptive cross-sectional survey conducted among 250 heads of households. RESULT: One hundred and seventy five (70%) respondents were aware of insecticide treated net as a means of prevention against malaria, 111 (44%) claimed to own insecticide treated nets. On further inspection of houses of those who claimed to own ITNs, seventy four (66%) actually had theirs hanged, the rest were either in their packs or not seen. Ninety five (38%) respondents out of the total sleep under insecticide treated net. About 92 (70%) households having under-five and 39 (81.3%) of households having pregnant women claim to use ITNs. It was observed that the level of education (chi2 = 48.35, p = 0.001), presence of under 5 children in a household ?2 = 7.229, p = 0.027) influenced ownership of Insecticide treated nets. In conclusion despite a high level of awareness about ITN found in this survey, ownership and utilization of insecticide treated nets were low.

Prevalence of Chlamydia trachomatis in sexual contacts of gonorrhoea.

The British national and local clinic guidelines recommend epidemiological treatment for Chlamydia trachomatis (CT) in patients with gonococcal infection but not their contacts. We aimed to determine the prevalence of CT amongst all gonorrhoea contacts attending over a 30 months period through a retrospective notes review. Of 223 contacts, gonorrhoea was diagnosed in 110 (49.3%) while CT was diagnosed in 54 (24.2%). CT was significantly more prevalent in younger people [(37.8% of contacts <25 years versus 9.6% of contacts >/=25 years (P = 0.000)]. All patients with CT identified as heterosexual except one. Amongst heterosexuals, there was no significant difference in the prevalence between males and females, being 31.6% and 27.8% respectively (P = 0.5995). CT was prevalent in 29.1% of N. gonorrhoeae positive contacts and 19.5% of N. gonorrhoeae negative contacts (p = 0.0935). The high prevalence suggests that epidemiological treatment for CT in gonorrhoea contacts is indicated.

[Melt granulation with glyceryl palmitostearate to obtain taste-masked acetaminophen]. / Masquage de goût du paracétamol par thermogranulation au palmitostéarate de glycérol.

A melt granulation process designed to obtain a taste-masked acetaminophen using glyceryl palmitostearte (Precirol Ato 5) is described. Melting this lipid material in a high-smear mixer gives granules which can be directly compressed after blending with the required excipients. The phase diagram shows the absence of interaction between the phases of the two components and no effect on acetaminophen polymorphism. A water dispersible tablet formulation is proposed for oral administration of cristallized acetominophen (500 mg) devoid of bitterness of which 90% dissolves within 15 minutes.

Quality of life and mood in renal transplantation recipients, donors, and controls: preliminary report.

Currently, living related donors are involved in approximately 85% of all kidney transplantations performed at our institution. Health-related quality of life (HRQL) is an important outcome factor in chronic disease. Quality of life may be diminished by prolonged illness or certain treatment modalities and by negative, disabling effects on mood. We investigated HRQL and mood in renal transplant recipients, donors, and controls using the Beck Depression Inventory, Beck Anxiety Inventory, and 36-item Short Form Health Survey. Recipient depression scores were significantly higher (indicating more serious depression) than those of donors (P <.05), but similar to those of the controls. There was no significant difference between the donor and the control subjects' depression scores. The anxiety scores of the recipients and donors were similar; and recipient anxiety scores were significantly higher than those of the control subjects (P <.05). The recipient scores indicated significantly poorer physical functioning (P <.001), significantly greater physical limitation on roles (P <.01), and lower levels of general health (P <.01) compared to controls. The recipient scores for vitality, pain, social functioning, and emotional limitations on roles were similar to those of the controls. Our results indicate that most recipients and donors experience anxiety after renal transplantation. This study confirms that recipients have favorable outcomes with respect to social functioning and emotional well-being. Overall, the results of this preliminary study are positive, encouraging us to continue to perform living donor kidney transplantation.

Rapid therapeutic response onset of a new pharmaceutical form of chloroquine phosphate 300 mg: effervescent tablets.

OBJECTIVE: To compare the efficiency, safety and taste of two pharmaceutical forms of chloroquine phosphate 300 mg: effervescent tablets against uncoated tablets. METHOD: An open randomized study with 60 adults who suffered from acute uncomplicated Plasmodium falciparum malaria in three health centres in Nkongsamba health district, Cameroon. RESULTS: Mean times to fever clearance, symptoms clearance and asexual parasites clearance were longer in the uncoated tablets group: 36 h (range 24-48 h, SD = 16.8) vs. 60 h (range 24-96 h, SD = 31.2, P = 0.001) for fever clearance, 36 h (24-48 h, SD = 16.8) vs. 48 h (24-72, SD = 24, P = 0.001) for symptoms clearance and 48 h (24-72, SD = 1) vs. 72 h (48-96, SD = 24, P = 0.001) for parasitaemia clearance. Uncoated tablets took significantly longer to achieve 50% reduction of the initial asexual parasite density: (mean/SD) 19.2 h/7 vs. 52.8 h/16.8, P < 0.00001. The adverse effects in the two groups were similar, P > 0.05. The cure rate at day 7 in the two groups was similar, P > 0.05. There was no chloroquine resistance in the effervescent tablets group but one RI and one RII resistance in the uncoated tablets group. The taste of the two pharmaceutical forms was significantly different, P < 0.00001. Effervescent tablets tasted sweet (score = 7.93), whereas uncoated tablets were bitter (score = 2.07). CONCLUSION: Effervescent tablets of chloroquine phosphate 300 mg work faster than uncoated tablets and because of their safe use and sweet taste achieve good therapeutic compliance.

A process to produce effervescent tablets: fluidized bed dryer melt granulation.

The purpose of the present study was to apply melt granulation in a fluidized bed dryer (fluidized bed dryer melt granulation) to manufacture one-step effervescent granules composed of anhydrous citric acid and sodium bicarbonate to make tablets. This study permitted us to establish that such process parameters as concentrations of polyethylene glycol (PEG) 6000, residence times in the fluidized bed dryer, fineness of PEG6000, fineness of initial mixture effervescent systems, and efficiency of two lubricants markedly affect some granule and tablet characteristics. It is a dry process that is simple, rapid, effective, economical, reproducible, and particularly adapted to produce effervescent granules that are easily compressed into effervescent tablets.

[The carbon dioximeter: a device for quantifying the carbon dioxide released from effervescent pharmaceuticals]. / Dioxycarbomètre: appareil de dosage du dioxyde de carbone dégagé par les formes pharmaceutiques effervescentes.

Since effervescent pharmaceuticals are more sensitive to ambient humidity during the manufacturing process and storage, the strict control of their carbon dioxide content becomes a prerequisite to guarantee their physicochemical stability. Indirect gravimetry is a simple and precise method that consists in taking the weight before and after the effervescent reaction allowing to determine the released amount of carbon dioxide. Some authors have used it with devices that lead to longer analysis times and poor accuracy of measurements (due to the excess of released carbon dioxide). The device that we have built (proposed name "CARBONDIOXIMETER") is very easy to set up, and yields quick, accurate, precise and reproducible results. An assay takes three minutes in an acidic medium and five minutes in carbon dioxide free water). Moreover, through the interconnection of scales, registration and treatment of the results can be performed by a printer or a computer. Thus, the "Carbondioximeter" is contributing to the control of physicochemical stability of effervescent pharmaceuticals during the manufacturing process and storage.

Process to manufacture effervescent tablets: air forced oven melt granulation.

In the present study we apply melt granulation in an air forced oven, called "are forced oven melt granulation" to the single-stage manufacture of effervescent granules consisting of anhydrous citric acid (43.2%) and sodium bicarbonate (56.8%) in order to make tablets. This study established that process parameters such as concentration of PEG 6000, residence time in the air forced oven, fineness of PEG 6000, fineness of the initial effervescent mix and efficiency of two lubricants markedly influenced several granule and tablet characteristics. The granules ready to be compressed into tablets were stable for 7 days at 60% RH/18 degrees C. It is a dry, simple, rapid, effective, economical, reproducible process particularly well suited to the manufacture of effervescent granules which are easily compressed into effervescent tablets. Of all the formulations tested, only formulations B2 and E2 melt granulated for 30 minutes gave tablets which had optimum compression characteristics without processing problems during compression.