JOURNAL OF DRUG DELIVERY AND THERAPEUTICS

1-4

Authors: M Santhosh Aruna, M Surya Prabha, N Santhi Priya, Ramarao Nadendla

India possesses a rich biodiversity of the medicinal plants that were still not explored completely. Catharanthus roseus is native to the Indian Ocean island of Madagascar. This herb is now common in many tropical and subtropical regions worldwide, including the southern United States. It is a popular ornamental plant found in gardens and homes across the warmer parts of the world. The need for the novel pharmaceutical products out from the plant has attained a great interest in the present research world due to the cost and the higher side effects that are associated with the chemically manufactured drugs. Catharanthus roseus, which is a potent medicinal plant many of the pharmacological actions. That is used to treat many of the fatal diseases. Alkaloids were the major phytochemical constituent of the above medicinal plant and have different types possessing various medicinal uses. This review highlights the marvelous properties of this plant. Key words: periwinkle, vinca, alkaloids, catharanthus, Madagascar

10-12

Authors: Raju Chipirishetti

Background and Objective: Impaired glucose tolerance and impaired fasting glycaemia are risk categories for future development of diabetes and cardiovascular disease. Apart from being the leading cause of renal failure, it also increases the risk of lower limb amputations, visual impairment and tuberculosis. Higher incidence of Diabetes Mellitus in the last decade has compelled us to conduct the present study with an objective to establish safety, efficacy and tolerability of gliclazide against glimepiride in the treatment of type 2 Diabetes Mellitus. Methodology: The present study was single centered, prospective and observational conducted after obtaining approval from the ethics committee. A total of 40 patients who visited the outpatient block of Apollo hospital at Jubilee Hills, Hyderabad were enrolled in the study. A questionnaire was used to record the response of subjects participated in the study. Results: A higher proportion of patients belonged to the age group of 41-50 years. Gliclazide did not result in any ADR while glimepiride caused eight ADRs. Average reduction of FBS and PPBS in gliclazide group was found to be 52.5% and 41.3% respectively. Corresponding figures for glimepiride were 56.9% and 32.3%. HbA1c reduction in gliclazide and glimepiride group was 2.44 and 1.91 respectively. Both drugs were found to be well tolerated by the patients. Conclusion: Gliclazide was found to be superior in terms of safety and efficacy. Hence it can be concluded from the study that gliclazide is a better option in diabetes when compared to glimepiride. Keywords: diabetes mellitus, efficacy, gliclazide, glimepiride, safety, tolerability

24-32

Authors: M Kadiri, A W Ojewumi, I O Bada

A survey study was carried out on plants used to manage kidney and liver diseases in Odeda Local Government Area, Ogun State, Nigeria. A total of hundred (100) questionnaire were administered using stratified sampling method on traditional herbal practitioners. Ethnobotanical data such as, plants and plant parts and methods of extraction used were sought. Anti-nutrients of the frequently mentioned plants were also evaluated. Data were subjected to Analysis of variance (ANOVA) with probability set at p<0.05 and descriptive statistics. Results revealed that 55.5% of the respondents were females while 45.5% were males. Largest percentage (47.9%) were between the ages 41-60years. Twenty six 26(26.0%) of the respondents were herbalists, 34(34.0%) were herb sellers, 21(21.0%) were Traditional practitioners while 19 (19.0%) were Traditional practitioners and herb sellers. Twenty three (23) of the respondents had 1-5years, 35 had 6-10 years while 42 of them had being in the herbal profession for more than 10 years. Seventy four percent (74%) of plants collated during this study were available both in home garden and markets. Fifty 50 plants species belonging to 37 families were reported being used to manage kidney and liver diseases. Malvaceae and meliaceae were the most frequently mentioned families. Largest number of plants 20(40%) collated were trees, followed by herbs 19(38%) while vegetable 1(2%) was vegetable. The most commonly used plants part were Leaves, barks roots, fruits, seeds bulbs and combination of any of these parts. Decoction, soaking, infusion, grinding, strong heating paste and combination(s) of any of these methods were employed for preparing herbal remedies of these diseases. No significant difference (P>0.05) was recorded in the phytate content of Khaya ivorensis and Kigelia africana leaves. Similar observation was recorded in the oxalate and cyanide content of Chasmantheran dependens and Kigelia africana leaves.. Polyphenol and tannins were significantly different across the leaves of plants under this investigation. No significantly different (P>0.05) was recorded in the quantity of phytate present in Chasmantheran dependens and Kigelia africana, oxalate of Chasmantheran dependens, Kigelia africana and Azadirachta indica, and cyanide in root of the plants. Highest phytate (13.00) was recorded in Azadirachta indica, oxalate (12.33), Polyphenol (9.00) and cyanide (4.33) in Ficus exasperate while tannins (16.00) were recorded in the leaves of Chasmantheran dependens. Keywords: Ethnobotanical data , Anti-nutrient content, Kidney and Liver disorders

33-42

Authors: M Kadiri, A W Ojewumi, T N Onatade

A survey of plants used for the treatment of menstrual disorders and after-child birth problems was conducted in Abeokuta South Local Government. Hundred (100) questionnaires were administered using multi stage sampling method on traditional herbal practitioners. Ethnobotanical information such as, plants and plant parts used, methods of extraction used and mode of administration of the herbal preparations of these plants were requested. Also, phytochemical contents of the most frequently mentioned plants were determined. Data were subjected to Analysis of variance (ANOVA) with probability set at p<0.05 and descriptive statistics. Results revealed that a total of fifty-six (56) plants belonging to 37 families were mentioned. The most frequently mentioned families are Euphorbiaceae, Leguminoceae, Anacardiaceae, Apocynaceae, Araceae and Combretaceae. Sesamum indicum, Dioclea sarmentosa, Clausena anisata, Anogeissus leiocarpus, Alafia barteri, Tetrapleura tetraptera, Daniella oliveri, Lannea egregia and Alstonia boonei were the most frequently mentioned plants used in the treatment of menstrual disorders and after-childbirth problems. Leaves (34%), fruits (7%), flowers (3%), tubers (2%), stem-barks (28%), seeds (11%) , roots and barks (2%) and roots (13%) were the plants reported being used for the remedy of these disorders. Decoction (54%), squeezing (9%), grinding/squeezing (14%), paste (4%), exudation (4%), cooking (4%), soaking/ decoction/infusion (4%), and heating to ashes (4%) were the methods of extracting the bioactive principles of the plants using water (79%) as major solvent. Significant difference (P < 0.05) was observed in the quantities of tannins recorded in the leaves of Sesamun indicum, Dioclea sarmentosa, Clausena anisata, Anogeissus leiocarpus and Alafia barteri. Similar observations were found in the quantities of saponnins, alkaloids, flavonoids and phenol. Highest values of tannins (0.32mg/g), saponnins (1.07mg/g), alkaloids (5.16mg/g), flavonoids (3.12mg/g) and phenol (0.09 mg/g) were determined in the leaves of Clausena anisata, Sesanum indicum, Dioclea sarmentosa and Alafia barteri. Across the roots of these plants, similar amount of tannins and saponnins were quantified. This observation varied significantly when compared with alkaloids, flavonoids and phenol quantified in the roots of plants. Highest tannins (1.67mg/g) and saponnins (3.33 mg/g) were recorded in the roots of Dioclea sarmentosa, alkaloids (4.33 mg/g) and flavonoid (6.33 mg/g) in Anogeissus leiocarpus while phenol (1.33 mg/g) was recorded in roots of Sesanum indicum. Key words: Menstrual Disorders, Childbirth Problems, phytochemical contents, Traditional practitioners, Indigenous plants

48-54

Authors: P K Makwana, K B Patel, J R Vyas, Umesh m Upadhyay

Aim of study was to develop bilayer drug delivery for treatment of spasticity by delivering loading and maintenance dose for fast achievement of peak plasma concentration and maintaining the same respectively. The prepared drug loaded bilayer tablets were evaluated for pre and post compression parameters. Stability study of the promising formulation was also performed. The tablets were prepared by direct compression and wet granulation method. The loading dose was delivered in the form of immediate release layer prepared by different super-disintegrations and maintenance dose was delivered through sustained release layer prepared by using polymers like HPMC K4, HPMC K15M, HPMC K100, PEO WSR 303 and Precirol. Both the immediate release layer and sustained release layers were separately optimized and then combined to optimize the bilayertablets. No interactions were found between drug and excipients. Formulation containing Kyron T314 shows immediate drug release. Formulation Containing PEO WSR 303 shows sustained release action and bilayer formulations F6 shows releases up to 24 hours. Bilayer tablets with release characteristics offer critical advantages such as, site specificity with improved absorption and efficacy. Key words: Baclofen, Bilayer tablet, sustain release tablet

62-71

Authors: S Patil, Venkatadri Ram Mohan Gupta

In view of chronobiological considerations of rheumatoid arthritis, the present study deals with the design and evaluation of multiparticulate system for the chronomodulated delivery of lornoxicam. The basic design is based on the Pulsincap technology and consisted of formaldehyde treated insoluble hard gelatin capsule body filled with tripolyphosphate cross-linked chitosan microspheres of lornoxicam and sealed with a hydrogel tablet plug. The entire device was enteric coated, so as to prevent the variable gastric emptying time. The microspheres were found to be discrete, nearly spherical with rough surface characteristics. Particle size, encapsulation efficiency and release rate of lornoxicam from the microspheres are dependent on the fabrication conditions of the microencapsulation. FT-IR, DSC and XRD studies revealed the compatibility of the drug with the excipients used. The exposure of hard gelatine capsule bodies with formaldehyde for a period of 12 hrs was found to be optimum in maintaining the intactness of the capsule bodies in the simulated GI fluids. The lag time of the designed delivery system varied from 4-8 hrs and depended on the nature and concentration of the plugging material. The ejection of the plug was delayed with increase in the polymer concentration. Among the two polymers studied as plugging materials, guar gum exhibited better control in maintaining the lag time compared to xanthan gum. From the study it can be concluded that, the lag time be efficiently tailored by varying the concentrations of the polymers in the hydrogel plug for the chronomodulated delivery of lornoxicam. Key Words: Rheumatoid arthritis; Lornoxicam; Microspheres; Chronomodulated delivery systems; Hydrogel plug; Lag time;

76-79

Authors: BN Poornima Rao, S K Bhat

Respiratory allergies constitute one of the major allergic disorders affecting children at global level. In the Renuka Diagnostics Laboratory, serum samples of 280 children (aged between 05-11) were tested for Inhalation allergy (IgE) on commonly occurring airborne allergies. The study has confirmed house dust mites and dermatrophs as the major cause of respiratory allergies among children. Strict avoidance of allergens is the only well-established management strategy for the disorder. Key Words: Asthma, Rhinitis, Inhalation, Anaphylaxis, Immunological reaction, allergic reactions.

87-91

Authors: RY Shah, RK Jat

A simple, accurate rapid and precise RP-HPLC method has been developed and validated for determination of Ceftriaxone in bulk drug. The RP-HPLC separation was achieved on Promosil C-18, (250 mm, 4.6 mm, 5µm) using mobile phase buffer: methanol ph 6.8 (90: 10 v/v) at flow rate of 1.0 ml/min at ambient temperature. The retention times were 7.111 min. for Ceftriaxone. Calibration plots were linear over the concentration range 1-20µg/ml. Quantification was achieved with photodiode array detection at 260 nm over the concentration range of 1-50 µg/ml. The method was validated statistically and applied successfully for the determination of Ceftriaxone. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of Ceftriaxone in bulk drug. Keywords Ceftriaxone, Water, Buffer, Validation, HPLC.

96-100

Authors: RY Shah, RK Jat

A simple, sensitive, fast & precise Reverse Phase High Performance Liquid Chromatographic method was developed for the determination of Cefotaxime Sodium in pharmaceutical dosage form. The RP-HPLC separation was achieved on hypersil C18 column (250 mm, 4.6 mm, 5µm) using mobile phase consisting of buffer solution (sodium dihydrogen phosphate) : acetonitrile [37: 63 v/v, pH=2.75 adjusted with phosphoric acid] at a flow rate of 1ml/min and the retention time was about 6 minutes. The method is selective to Cefotaxime Sodium and able to resolve the drug peak from formulation excipients. The system suitability with retention time was (Mean + %CV) 8.600 + 0.186.The calibration curve was linear over the concentration range of 1-20µg/ml (r2 = 0.999). The proposed method is accurate and precise (Intra day and Inter day variation, RSD were 0.55-1.67) and linear within the desired range. The LOD and LOQ was detected as 0.0187µg/ml and 0.043µg/ml respectively with r2 = 0.9997. The accuracy result of seventy percent drug (80%) was 99.87%, hundred percent (100%) was 99.93%, and one thirty percent (120%) was 100.18%. Therefore, this method could be used as a more convenient and efficient option for the analysis of Cefotaxime Sodium in raw material and Parentral dosage form. Keywords: Third generation cephalosporin; Cefotaxime Sodium; Method validation; HPLC method determination; Quantitative analysis