Spectrophotometric method development and validation for determination of chlorpheniramine maleate in bulk and controlled release tablets

Spectrophotometric technique is considered to be the simplest and operator friendly among other available analytical methods for pharmaceutical analysis. The objective of the study was to develop a precise, accurate and rapid UV-spectrophotometric method for the estimation of chlorpheniramine maleate [CPM] in pure and solid pharmaceutical formulation. Drug absorption was measured in various solvent systems including 0.1N HCl [pH 1.2], acetate buffer [pH 4.5], phosphate buffer [pH 6.8] and distil water [pH 7.0]. Method validation was performed as per official guidelines of ICH, 2005. High drug absorption was observed in 0.1N HCl medium with lambdamax of 261nm. The drug showed the good linearity from 20 to 60microg/mL solution concentration with the correlation coefficient linear regression equation Y= 0.1853 X + 0.1098 presenting R2 value of 0.9998. The method accuracy was evaluated by the percent drug recovery, presents more than 99% drug recovery at three different levels assessed. The % RSD value

Effects of superdisintegrants in oral dissolving formulation of cinitapride tablets

The initiation of newer techniques and development of mouth dissolving [MD] products has created new avenues of higher patients' compliance. MD formulations are actually lessen the difficulties associated with solid swallowing with better bioavailability of especially poorly soluble drugs. In the current study mouth dissolving tablet [MDT] formulations of cinitapride [1 mg] were prepared by direct compression method using various proportion and combination of superdisintegrants. Nine formulations in three batches were compressed by incorporating low [2%], intermediate [6%] and higher [10%] levels of crospovidone, croscarmellose sodium, sodium starch glycolate. Micromeritic assessment of the powder blends were carried out and were found within the acceptable official limits. All newly developed trial formulations were exposed to different pharmacopoeial and non-pharmacopoeial testing. It was found that FC2 trial tablets containing polyplasdone XL [crospovidone] at level of 6% [4.5 mg] presented the best physico-chemical attributes deemed to be desirable for the ODT products. Disintegration and wetting time of optimized FC2 was computed between 15-17 and 12-15 seconds respectively. The assay and content uniformity of FC2 were estimated to be 100.02+/-0.36 and 99.66+/-1.70 percent correspondingly. On the basis of the findings it was concluded that MDT could be successfully developed by incorporating appropriate concentration of superdisintegrant and their combinations

Formulation design, characterization and optimization of cinitapride [1mg] immediate release tablets using direct compression technology

Cinitapride hydrogen tartarate is relatively a new prokinetic agent that widely prescribed for GERD and epigastric pain. Present study was aimed to develop and optimize cinitapride [1 mg] immediate release [IR] tablet formulation[s] by direct compression using central composite rotatable technique. Overall nine formulations [FC1-FC9] were generated by varying the composition of binder avicel PH 102 [X1] and superdisintegrant crospovidone [X2]. The effect of interaction of excipients on hardness [Y1], friability [Y2], disintegration [Y3] and dissolution at 15 min [Y4] were analyzed by RSM plotting. On the basis of physico-chemical evaluation FC3, FC4 and FC6 were found to be the optimized formulations however; FC3 was selected to be the best trial owing to excellent drug release [100.17%] with least friability [0.14%]. These IR tablets showed the release pattern similar to the Weibull model with r2 value of 0.9780.998. The dissimilarity [f1] and similarity indexes [f2] of FC3, FC4, FC6 with the marketed product were estimated to be 2.57 and 76.51, 4.51 and 64.46, 4.32 and 66.78 respectively. Trial optimized formulations were highly stable with the shelf lives of 58-64 months. So, keeping in view the results of present investigation, it is concluded that the technique of manufacturing and optimization is found to be excellent for developing immediate release cinitapride tablets

Development and validation of stability indicating assay method for cinitapride in bulk and tablets

A simple stability indicating UV-spectrophotometric method has been developed and validated for the determination of cinitapride hydrogen tartrate [CHT] in bulk and solid pharmaceutical dosage form. Drug absorption was measured in different analytical mediums however; maximum absorption was seen in 0.1 N HCl at wavelength [lamda [max]] of 266 nm. The calibration curve was found to be linear over the concentration range from 6 to14 micro g/mL with the correlation coefficient value [r] of 0.999. The LOD and LOQ were estimated to be 0.1019 micro g/ml and 0.309 micro g/ml respectively. The accuracy was evaluated by determining the percent drug recovery, performed at three different levels of 50%, 100% and 150%. The% recovery was found to be in the range of 99.96-100.64%. The precision of the method was determined by inter-day and intra-day variations. The % RSD value <0.5 indicates the underlying method is precise and accurate as well. The developed method was applied to characterize in vitro assay content of few brands of cinitapride [1 mg] available in local market. No interference of the formulation excipients with the drug absorption was observed during assay. Drug substance and drug product were exposed to various stressed conditions [acid, base, oxidative, thermal and photolysis]. Forced degradation testing of drug product showed that the oxidation [20%] was found to be the major degradation pathway of the cinitapride. However; drug estimation was not influenced in presence of degradation moieties formed during acid, base, oxidation, thermal and photolytic breakdown. Overall, the investigated technique is robust and specific that would be successfully used to quantify the cinitapride hydrogen tartarate in pharmaceutical dosage and bulk form in future

Evaluation of nephrotoxicity by aspirin-clopidogrel combination therapy in patients with acute coronary syndrome

Although aspirin-clopidogrel combination is more useful for acute coronary syndrome [ACS], the renal safety of this combination had not been established. A total 60 patients with ACS were divided into three groups; receiving aspirin, clopidogrel and aspirin-clopidogrel combination. For determination of renal function, serum BUN, creatinine, uric acid, uric acid clearance and GFR were estimated for four months. The study showed that there were no significant [p>0.05] variations in the parameters when used the drugs in combination [aspirin-clopidogrel] compared with the drugs given alone

Weight loss due to maxillomandibular fixation in mandibular fractures

The aim of this study was to calculate extent of weight loss [in kilograms] due to Maxillomandib-ular fixation in patients after trauma. Study design was prospective observational study. The study was conducted in Oral and Maxillofacial Surgery Department, Armed Forces Institute of Dentistry, Rawalpindi from February 2014 to July 2014 over a period of 06 months. A total of 30 patients with only mandibular fracture were included in the study. Out of these 30 patients 27 patients were males and 03 patients were females. All patients were treated with Max-illomandibular fixation for 04 weeks. Weight of the patient was noted pre-operatively, 1st week post operatively and 4th week post operatively. Data was analyzed using SPSS version 20. The study included 30 patients with mean age of 36.67 [SD +9.743] out which 90% were male and 10% were female. The overall weight loss sustained by patients in this study was 6 kilograms [kgs] at the end of first week post operatively and 5kilograms [kgs] at fourth week post operatively when compared with their weights before surgery. Within the limitations of this study, significant weight loss was observed at the first week post operatively among all patients

Ajwa Date [Phoenix dactylifera]: an emerging plant in pharmacological research

Date Fruits are consumed in Arab areas for a long time as a part of essential diet. Phoenix dactylifera belongs to family Arecaceae and its leaves, barks, pits, fruits and pollens have anticancer, antioxidant, hepatoprotective, antidiabetic, antihypertensive, antiulcertavie, anti-inflammatory, antiproliferative, antimutagenic, antidiarheal, antibacterial, antifungal and antiviral potential. Besides these, Dates also increase level of estrogen, testosterone, RBCs, Hb, PCV, reticulocytes and platelet counts. It can also cure lead induced heamotoxicity, side effects of methylprednisolon, male and female infertility. It has also cerebroprotective, neuroprotective and haemopoietic activity. Phoenix dactylifera can be used for number of complications if further evaluated and isolated. The present paper is an overview of pharmacological properties of Phoenix dactylifera reported in literature.

Management of dry socket: a comparison of two treatment modalities

The objective of this study was to compare the effect of local application of chlorhexidine digluconate and combination of lodoform with Butylparaminobenzoate in the management of dry socket. A Quasi experimental study was carried out on a total of sixty diagnosed cases of dry socket. Patients were randomly distributed among two treatment groups [30 patients in each group] i.e. patients of group A were treated by local application of chlorhexidine digluconate gel and of group B by local treatment with combination of lodoform + Butylparaminobenzoate [Alvogyl]. Both the treatment groups were given the same systemic analgesic i.e., Ibuprofen 400mg TDS along with thorough irrigation of the socket. Patients were followed for five consecutive days by replacing dressing each day and findings were recorded in the pro forma. Out of the sixty patients, forty five were males and fifteen were females [3:1]. In group A there were 22 [73.33%] males and 8 [26.66%] females and in group B there were 23 [76.66%] males and 7 [23.33%] females. Mean age was 31.68 [11.23+S.D]. There was no significant effect of gender [P=0.766] and age [P=0.668] on both of the treatment groups respectively. All patients measured their pain subjectively as S3 i.e. severe pain on day 1 on visual analogue scale. There was a significant difference in pain control of the two treatment groups on 2nd, 3rd and 4th treatment day with P=0.000, P=0.000 and P = 0.02 respectively. Significant difference was noted for sensitivity on gentle probing the extraction socket between the results of two treatment groups on 3[rd] and 4[th] day i.e. p=0.000 for both days. lodoform and Butylparaminobenzoate [Alvogyl] had been the most successful combination in relieving patient's pain

Post-operative complications associated with impacted mandibular third molar removal

The objective of this study was to evaluate the occurrence of post-operative complications after surgical removal of impacted mandibular third molar. This descriptive study was carried out at the Department of Oral and Maxillofacial Surgery, Khyber College of Dentistry, Peshawar. One hundred and six patients were included in this study. Detailed history was taken front each patient. Data were collected on a specifically designed pro forma. The patients were re-evaluated on the third and seventh post-operative days. Post-operative complications recorded were based on history, clinical examination and radiographs when necessary. The data were analyzed using SPSS 17. The most common age group was the third decade [58.5%]. Mesioangular [42.5%] and class 1A [43.4%]were the most common pattern. The most common post-operative complications were swelling [92.5%], pain[88.6%] and trismus[81.1%] followed by nerve injury[6.6%], dry socket [3.8%] and infection[2.8%]

Retaining or extracting a tooth in the line of mandibular fracture - a study

The purpose of the study was to compare the treatment outcome of extractions and nonextractions of teeth in the lines of mandibular fractures and to determine the most common complications. A Quasi-experimental study was undertaken in the Department of Oral and Maxillofacial surgery, Khyber college of Dentistry Peshawar from January 2007 to January 2008. A total of 100 patients having tooth in the line of mandibular fracture were recruited in the study. The patients were divided into two groups of 50 patients each. In Group A the tooth was retained in the line of fracture, and while in Group B the tooth was extracted. Each patient was evaluated for postoperative results and the differences between them assessed. Statistical analysis included chi-square test. Results were considered significant if p d" 0.05. Majority of the patients were young adults. The most common site was parasymphysis while the most commonly involved teeth in the fracture line were incisors. The major operative morbidity proved to be infection followed by malunion and maloclusion. Both groups were not different in relation to postoperative infection [P= 0.461], malocclusion [P= 0.5577], malunion [P= 0.5577] delayed union and non-union. There was no significant difference in the outcome between the extraction and non-extraction of a tooth in the line of fracture

Comparison between topical bacitracin and neomycin with pyodine for prophylaxis against wound infection in appendicectomy

To compare the efficacy of prophylactic use of topical Bacitracin-Neomycin [Bivalek spray] with pyodine [solution] against wound infection in appendicectomy. Random control trial. Department of Surgery, Military Hospital Rawalpini, Pakistan. One year from 15 Jan, 2007 to 14 Jan 2008. A total of 100 patients of acute appendicitis who underwent appendicectomy. Patients were randomly allotted to either group A in which the post appendicectomy wound sepsis was managed by using Bacitracin-Neomycin [n=50] or to group B, in which wound was managed by using pyodine [n=50]. Outcomes were measured by absence or presence of oedema, discharge from the wound and erythema at wound site, wound dehiscence or fistula formation. Comparison between two groups revealed infection rate of 14% in group A and 8% in group B with no significant difference in wound infection [p value = 0.388]. Topical Bacitracin-Neomycin [Bivalek Spray] is equally effective as pyodine for prophylaxis against wound infection after appendicectomy

frequency of caries in school going children of Peshawar

To determine the frequency of dental caries, the gender distribution, the most commonly involved deciduous and permanent tooth in dental caries and to evaluate tooth brushing habits in school going children of Peshawar. This descriptive study consisted of 1000 children aged between 6 to 14years old. The information was gathered by taking a detailed history and clinical examination of the students and noted in a structured questionnaire. Brief biodata and oral hygiene levels were recorded in descriptive form while the carious teeth were recorded in tabulated form. Data was analysed using SPSS 10. Out of a 1000 students, 642 [64.2%] had caries. The caries distribution was more in boys [54%] as compared to girls [46%], with male to female ratio 1:0.85. The highest prevalence of caries was found in 12 year old children [77%]. Highest numbers of caries were found in first molar in both primary [262] and permanent dentition [188]. Thirty eight percent children claimed to have brushed their teeth once daily and 11.5% did not brush their teeth at all. Our study showed that there is a lack of awareness of oral hygiene and its importance has not been emphasised enough to the school going children

Pattern of zygomatic bone fractures and treatment modalities: a study

This study was designed to determine the pattern of zygomatic bone fracture, etiology and treatment options. The term pattern in this study was used for the sites/processes of zygomatic bone fracture. The variables evaluated were age, gender, sites of fracture and treatment options. A total of 81 patients with zygomatic bone fracture were treated in Oral and Maxillofacial Surgery unit, Khyber College of Dentistry, Peshawar for a period of one year from July 2007 to June 2008. Majority of patients were young males in 3rd and 4th decade. Male to female ratio was 12.5:1. Road traffic accidents [76.5%] were the most common and interpersonal violence 2.5% as the least common etiology of zygomatic bone fracture. In 28.4% patients, zygomatic bone was fractured at single site while in 71.6% it was fractured at more than one. Fracture at zygomatic buttress and infraorbital rim [27.2%] in combination was most common finding. Twenty three percent patients did not require treatment, 32.1% zygomatic bone fractures were reduced indirectly and 44.4% were reduced directly by open reduction and internal fixation

Frequency and demography of commonly occurring odontogenic cysts in Khyber Pakhtunkhwa [Pakistan]

The objective of the study was to determine the frequency and demography of commonly occurring Odontogenic cysts in Khyber Pukhtun Khwa [province of Pakistan] population. A descriptive [case series] study was carried out from October 11, 2006 to October 10, 2007 at Department of Oral and Maxillofacial Surgery, Khyber College of Dentistry, Peshawar. The frequency of common Odontogenic cysts was 2.6%. Majority were found in the age range of 11-20 and 21-30 years with a male to female ratio of 1.7:1. 71.4% Radicular and 64.3% Dentigerous cysts were found in the maxilla while 75% of Odontogenic Keratocysts were found in the mandible. The most common site of Radicular cysts in maxilla was Canine to Canine, for Dentigerous cysts it was Incisor/Premolar and Odontogenic Keratocysts were mostly seen in Incisor/Premolar/Molar region. The most common location of Radicular cysts in the mandible was Canine to Canine, Dentigerous cysts Molar and Odontogenic Keratocysts Molar/Ramus region. The present study gives sufficient knowledge about frequency and demography of common Odontogenic cysts in Khyber Pukhtun Khwa population

Frequency and reasons for the removal of stainless steel plates in maxillofacial trauma

This study was a retrospective chart review of the cases operated for maxillofacial trauma with plate osteosynthesis in Oral and Maxillofacial Surgery Unit of Khyber College of Dentistry Peshawar, Pakistan, and was designed to evaluate the frequency and various reasons for the removal of the stainless steel plates in maxillofacial trauma patients. It was conducted on patients who were treated with internal fixation using 2.0-mm stainless steel plates and screws. All data were obtained from the operation theater computer and operative ward charts. The variables evaluated were Age, Gender, and Site from where the plate has been removed and the cause of its removal. A total of 998 patients with maxillofacial trauma reported during the years 2006 and 2007 in this Unit. A total of 254 plates were used in the two year study period to fix various maxillofacial fractures. Types of fixations used were 2.0-mm stainless steel plates and screws. Majority of the patients were young i.e., below 40 years. Male to female ratio of the patients was 3.5:1. Out of the 254, 27 plates [10.63%] had to be removed. Mandibular body was the most common site followed by frontozygomatic suture from where the plates were removed. Infection was the most common cause of plate removal. Other reasons for the plate removal were infections and discharging sinus, plate fracture, parasthesia, pain, planned removal in children patients younger than 10 years and for psychological reasons. A few of the patients developed complications of plate osteosynthesis

Maxillofacial injuries in internally displaced persons

This study was conducted to evaluate the incidence of maxillofacial injuries and their causes in Internally Displaced Persons from Swat, Malakand Division, Bajaur and Waziristan .A total of 73 Internally Displaced Persons with various maxillofacial injuries admitted in the oral and maxillofacial surgical unit of Khyber College of Dentistry, Peshawar from May 2009 to October 2009 were included in the study. Males in their second decade of life were more in number. Maxillofacial trauma due to firearms [48%] and RTA [37%] were reported. Most of these patients were injured while they were outside their homes. Mandible [54.80%] was the most common bone fractured. Open reduction internal fixation was employed in 69.86% patients

Aetiology and pattern of maxillary fractures- a study

Maxillary bone is an important component of mid face guarding three vital cavities including oral, nasal and orbital. It plays an important role in aesthetics of a person. Maxillary fractures are very important when it comes to management because posterior and downward displacement of fractured maxilla can lead to airway blockage and death. A prospective study was undertaken to determine the factors leading to and pattern of presentation of isolated maxillary fractures over a period of One year from 4 th October 2006 to 3 rd October 2007 at Department of Oral and Maxillofacial Surgical Unit Khyber College of Dentistry Peshawar. The study was carried out on 60 patients with maxillary fractures to identify factors leading to maxillary fractures and to describe the pattern of presentation of maxillary fractures. They were inquired about the factor causing injury and thoroughly examined both clinically and radiologically for pattern of fracture as well as for any other facial bone fracture. The age, gender, factors and pattern of maxillary fracture of the patients were determined. Maxillary fractures occur over age, ranging from 4 years to 70 years with mean age of 28.1 years SD +/- 14.54. Male to female ratio was 13.28:1. This shows that male patients were predominantly affected. Road traffic accidents [RTA] contributed for 65% of maxillary fractures. Le Fort II was the most common maxillary fracture i.e 45%, followed by Le fort I 26.7%, while Le Fort III was the least common 11.7% and no isolated palatal split was found. The maxillary Le Fort II fractures are the most common fractures in Peshawar. Such injuries are resulted mostly because of Road Traffic Accidents. Implementation of strict Road traffic legislations are important to prevent such injuries

Clinical and radiological behaviour of ameloblastoma of the jaws

Ameloblastoma is the most frequent odontogenic benign but locally invasive neoplasm consisting of proliferating odontogenic epithelium with various amounts of surrounding fibrous tissue. The purpose of the study was to evaluate the clinical and radiological features of patients with mandibular and maxillary ameloblastoma at Khyber College of Dentistry Peshawar. The study was carried out on 19 biopsy confirmed cases of ameloblastoma, in Oral and Maxillofacial Surgery unit Khyber College of Dentistry Peshawar for a period of 1 years and two months me, from January 2004 to February 2007 RESULTS The age range of patients with ameloblastoma was from 10 years to 58 years with a mean age of 26 0 years SD +/- 11.6. Most of the patients were affected in their second and third decade of life i.e., 21.1% and 52.7% respectively Male to female ratio was 1.4:1. The mandible was predominantly involved by the tumour 84% while maxilla was involved in 16% of cases. Posterior mandible [63.2%] and anterior maxilla [10.5%] were the favorite site for the tumour in mandible and maxilla respectively The most common presenting complaint of the patients with ameloblastoma was painless swelling [63%]. Multi-locular radiolucency [57.9%] was the most common radiological pattern of the tumour. Ameloblastoma was common In younger age group where posterior part of the mandible was the most common site of involvement Painless swelling ha', been the most common clinical presentation Multi-locular radiolucency was the common radiological presentation in this study

Pre existing malnutrition and treatment outcome in children with acute lymphoblastic leukaemia

To assess the effects of pre-existing malnutrition on the treatment outcome of children with acute lymphoblastic leukaemia. One hundred and sixty three patients with Acute Lymphoblastic Leukaemia [ALL] below the age of 14 years with L1 and L2 FAB morphology were included in this study. Treatment protocol used was FBM. Patients were classified according to Waterlow classifications of malnutrition [1976].Group-I, as Under-Nourished children [UNC] and Group-II as Well-nourished children [WNC]. Percentages in both groups were calculated with respect to total expired, relapses and completed treatment. In Group-I [UNC] 46% completed treatment and were alive, 9.8% relapsed and 45% expired. In Group-II [WNC] 59% completed treatment and were alive, 21.3% relapsed and 19% expired.Overall, in WNC group 13.5% completed treatment and were alive, 8% relapsed and 7.3% expired. In UNC group 28.8% completed treatment and were alive,6% relapsed and 27% expired. Pre-Existing malnutrition adversely effects the treatment outcome in children with Acute Lymphoblastic Leukaemia [ALL]

Effect of hypoproteinemia on treatment outcome in children with acute lymphoblastic leukemia

Malnutrition is prevalent on large scale in hospitalized patients which increases morbidity and mortality, reduces the effectiveness of medical treatment in our hospitals and impairs the quality of life significantly. Early diagnosis and treatment of malnutrition is gaining the significance day by day. A prospective study was carried out to assess the effects of hypoproteinemia malnutrition on the treatment outcome of children with acute lymphoblastic leukemia. One hundred and sixty three patients with Acute Lymphoblastic Leukemia [ALL] below the age of 14 years with L1 and L2 FAB morphology were included in this study. Treatment protocol used was FBM. Patients were classified according to Waterlow classifications of malnutrition [1976]. Group-I, as Well-Nourished children [WNC] and Group-II as Mal-nourished children [MNC]. Percentages in both groups were found out with respect to total expired, Relapses and completed treatment. In Group-I [WNC] 50 [81.96%] completed treatment and alive, 5 [8.19%] relapsed and 6 [9.8%] expired. In Group-II [MNC] 31[30.39%] completed treatment and alive,8 [7.84%] relapsed and 63 [61.76%] expired. Overall, in WNC group-I 50[30.67%] completed treatment and alive, 5 [3.07%] relapsed and 6[3.68%] expired. In MNC group-II 31 [19.02%] completed treatment and alive, 8 [4.91%] relapsed and 63 [38.65%] expired. Hypoproteinemia affects treatment outcome in children with acute Lymphoblastic Leukemia