American Journal Of Pharmacy And Health Research

ISSN NO.: 2321-3647
July 2013 Issue 4

Minireview: Process Validation as Essential Tool in Pharmaceutical Industry

Sandip P Dholakia*1, Anil P. Valiya1, Tejas M. Thakar1,Jitendra S. Patel1Madhabhai M. Patel1

1. Department of Chemistry, Shankersinh Vaghela Bapu Institute of Pharmacy, Vasan-Gandhinagar (Gujarat)


Process validation is an important tool in modern pharmaceutical industry. Validation gives a quality proof to the product which was manufactured under specified condition and quality parameter defined by GMP. The process validation is established documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. If each step of manufacturing process is validated, we can assure that the final product is of desire quality. Validation of the individual steps of the processes is called the process validation. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test. This article covers Introduction, type of validation, Phases of Process Validation, Documentation, SOP, Validation Master Plan and Validation Protocol. Validation is an integral part of quality assurance, during the formulation of any product quality has always been an important factor and therefore training is required before moving on at every step such as manufacturing material, equipment, process and procedures so that the quality of the product may be regulated.

Keywords: Process Validation, Process Validation Stages, Validation master plan, protocol, quality control.


Phytochemical Investigation of the Rhizomes of Sansevieria Roxburghiana

Arun Joshi1*, Maya Bhobe1, Gauri Pai Angle1

1.Department of Pharmacognosy, Goa College of Pharmacy, Panaji -Goa


The present study reports the phytochemical investigation of the rhizomes of Sansevieria roxburghiana belonging to the family Dracanaceae. Nine phytoconstituents have been reported namely Palmitic acid, 6,4-dihydroxy-3-propen chalcones, 4-propenoxy-7-hydroxyanthocyanidines, Caftaric acid, Isorhamnetin-3-O-β-D-glucopyranoside, Di-(2-ethylhexyl) phthalate, Buphanidrine, Gallic acid and Di-isobutyl phthalate. These isolated compounds are reported for the first time from the rhizomes of Sansevieria roxburghiana.

Keywords: Sansevieria roxburghiana, Buphanidrine, Dracanaceae


Tectona Grandis: Phytochemical Investigation

Arun Joshi1*, Maya Bhobe1, Apurva Pednekar1

1.Department of Pharmacognosy, Goa College of Pharmacy, Panaji-Goa. 403 001


The present study reports the phytochemical investigation of the stem bark of Tectona grandis. Nine phytoconstituents have been reported namely Eicosanyl Eicosanoate, β-Sitosterol, Ursolic acid, Lupeol, Betulinic acid, Betulin, Betulinaldehyde, Bis (2-ethylhexyl) phthalate and Tectol. Eicosanyl eicosanoate and Bis (2-ethylhexyl) phthalate have been reported for the first time from stem bark of T. grandis.

Keywords: Tectona grandis, Verbenaceae, Bis (2-ethylhexyl) phthalate, Tectol.


Synthesis and Characterization of Novel Heterocyclic Compounds

K.M. Shailaja1,  B. Shivakumar*2 E. Jayachandran1,G.M. Sreenivasa1 and Sriranga T1

1 S.C.S College of pharmacy, Harapanahalli. Karnataka, India

2. B.L.D.E.A’s College of pharmacy, B.L.D.E. University Campus, Bijapur Dist. Karnataka, India


2-amino-6-fluoro-7-chloro (1,3) benzothiazoles is treated with six different aldehydes to get six different Schiff’s base (Azomethine) in presence of ethanol and HCl, then all the Schiff’s bases are separately refluxed with thioglycolic acid in presence of the solvent dioxane and triturated with NaHCO3 solution, as six different parent compounds. The resulted six azomethine (Schiff’s base) are treated with chloro acetyl chloride, triethylamine in presence of dioxane results gives six different, the parent compounds were treated with various aromatic primary and secondary amines in presence of Dimethyl formamide (DMF) gives various derivatives. Further, they have been screened for their antimicrobial, antiinflammatory (in-vitro and in-vivo) anticonvulsant and anthelmintic activity by standard method.

Keywords; Fluorine, Schiff’s base, Thiazolidinone and Azetidinone


Hydrocortisone Micro Emulsions for Parenteral Drug delivery

Swati Rawa1*

1.SND College of Pharmacy, Yeola, Nashik, (M.S.): 423401


Microemulsions are the promising vehicle for administration of active pharmaceutical ingredients. It is an isotropic transparent or translucent thermodynamically stable mixture and used for targeted controlled drug delivery system for the effective delivery of hydrocortisone.  In present study lecithin based o/w microemulsion was developed for parental drug delivery using hydrocortisone as model drug.  Tween 80 and Cremophor–EL were used as co-surfactant and PEG 400 were used as co-solvent; soyabean oil was used as the oil phase.  Formulations prepared with the tween-80 were having both clarity and maximum oil entrapment formulation prepared were characterized for color, appearance pH, viscosity, particle size distribution, Refractive index, effect of centrifugal force, freeze thaw cycle, drug content   in-vitro release profile and TLC.  Prior to stability studies the microemulsion were sterilized by autoclaving. Toxicity studies were performed on Albino mice by injecting them intraperitonialy no mortality was observed, which indicate the safety of these formulations. Therefore the lecithin based microemulsions can be formulated for parenteral drug delivery and obtain sustained or prolonged drug delivery for hydrocortisone having good physical stability.

Keywords: Microemulsions, parenteral drug delivery, thermodynamic stable systems, and toxicity studies.


Physicochemical and Phytochemical Investigation of the roots of Grewia Microcos linn.

Arun Joshi1*, Maya Bhobe1, Ashma Sattarkar1

1.Department of Pharmacognosy, Goa College of Pharmacy, Panaji-Goa. 403 001


The present study was undertaken for the development of physicochemical and phytochemical parameters of the roots of Grewia microcos Linn. belonging to the family Tiliaceae. In Hindi it is known as Shiral and Konkani as Chivra or aasale. Physicochemical and phytochemical investigation confirms the purity and authenticity of the roots of  Grewia microcos using standard methods. Physicochemical studies of the crude powder of the roots revealed the moisture content as 7.5%w/w, Swelling Index as 1.3 cm, Foaming Index as 454.44,  Alcohol soluble extractive as 0.244%w/w, Water soluble extractive as 0.232%w/w, Ether soluble extractive 0.04%w/w. Total Ash as 5%w/w, Water soluble ash as 2.15%w/w and Acid Insoluble ash as 2%w/w. Fluorescence analysis is a tool to determine the chemical nature of the crude drug which is reported in short wavelength, Long wavelength and day light. The preliminary phytochemical screening of the ethanolic extract of the roots revealed the presence of alkaloids, carbohydrates, tannins, saponins, triterpenoids and steroids. All these methods will help in laying down the pharmacopoeial standards in determining the quality and purity of the roots of Grewia microcos.

Keywords:  Grewia microcos, Tiliaceae, Physicochemical, Fluorescence analysis.


Formulation, Optimization and Evaluation of Niosomal Gel of Alitretinoin

Geeta M. Patel *1 Darshan R. Parmar1

1.Department of Industrial Pharmacy, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva-384012, Gujarat, India


Alitretinoin is used in treatment of AIDS related Kaposi’s sarcoma in concentrations of 0.1%. Alitretinoin is very effective but it causes skin erythema on the applied area. The Niosomes seems to be promising drug delivery in modern drug delivery systems. The main benefit over liposome is that the lipids are replaced by non-ionic vesicles and hence the preparation is totally non-antigenic. The non-ionic surfactants like SPANs and TWEENs are obtained from synthetic sources and hence the quality is maintained same all the time. The Alitretinoin was incorporated into niosomes using SPAN 60 and cholesterol. Various ratios of SPAN 60 and cholesterol were tried and optimized for the preparation of niosomes. Various process parameters were also optimized for the rotary flask evaporation method. The niosomal dispersion was incorporated in to carbopol 971NF gel. The gel was kept for 6 weeks accelerated stability studies. The niosomal dispersion was evaluated for various parameters like vesicle size, shape and morphology by Scanning electron microscopy (SEM) and Transmission electron microscopy (TEM). In-vitro and ex-vivo studies were carried out. The drug release pattern from gel was evaluated on the basis of in-vitro studies and skin irritation studies on rat skin. The in-vitro study shows sustained release gel effects whereas the ex-vivo study shows no signs of irritation on the applied skin area.

Keywords: Niosome, Alitretinoin, Span 60, Factorial design


Aqueous extract of ginger ameliorated enzymic& non enzymic antioxidant markers in selected brain regions during ethanol withdrawal induced oxidative stress

Swaroopa. Marella1*,Sathyavelu Reddy Kesireddy2

1.Division of Zoology, Department of Sericulture, Sri PadmavathiMahilaVisvavidyalayam, Tirupati-517502, Andhra Pradesh, India.

2.Division of Exercise physiology and Molecular Biology, Department of Zoology, Sri Venkateswara University, Tirupati-517502


Alcohol withdrawal (AWD) is characterized by signs of major oxidative stress and the loss of neural cells. The present study was designed to investigate the role of the total aqueous extract from rhizomes of ginger on ethanol withdrawal related oxidative stress and related damage  in brain regions of rat. α- Lipoic acid (ALA) (100 mg/kg b.w., i.p.) was used as a standard drug. Silymarin (100 mg/kg b.w., o.p.), a well known antioxidant was used for comparision. The ginger extract improved the level of protective antioxidants such as glutathione peroxidase (GPx), reduced glutathione (GSH), glutathione reductase (GRD), superoxide dismutase (SOD) and catalase (CAT) and inhibited XOD activity in the brain regions under study at a dose of 200 mg/kg, p.o. compared to silymarin or ALA or both combined. Moreover, a decline in the antioxidant enzyme level was observed during chronic ethanol administration too (20% ethanol @ mg/kg, p.o.). Interestingly, significant improvement was recorded with the supplementation of ginger extract by an improvement of the antioxidant enzyme status even in rats with chronic ethanol administration. In addition, a striking difference is observed in the decline in absorbance at 540 nm that reflects mitochondrial PTP opening of rats treated with ginger extract during chronic ethanol administration and ethanol withdrawal compared to rats that are subjected to the identical stress but without extract treatment. The current results indicate the possible utility of ginger rhizome in neuroprotection against neurodegenerative alcohol associated disorders such as ethanol withdrawal.

Keywords: Ginger; Alcohol Withdrawal; Oxidative Stress; Antioxidant System; Neurodegeneration