Dr.Mukesh Gohel

Dr.Mukesh Gohel's picture
Organization: 
L. M. College of Pharmacy, Opposite Gujarat University, Navrangpura, Ahmedabad, 380 009, Gujarat, India
Job Title: 
Principal
Degree(s) awarded: 
M-Pharm, PhD
College(s) Studied: 
L. M. College of Pharmacy, Opposite Gujarat University, Navrangpura, Ahmedabad, 380 009, Gujarat, India
Country: 
India
Zip(pin)code: 
380 009
Publications: 

Latest Paper:
Pharm Dev Technol. 2008 ;13 (5):447-56 18798122 (P,S,G,E,B)
Design of a potential colonic drug delivery system of mesalamine.
[My paper] Mukesh C Gohel, Rajesh K Parikh, Stavan A Nagori, Mahesh R Dabhi
Department of Pharmaceutics and Pharmaceutical Technology, L.M. College of Pharmacy, Ahmedabad, India.
The aim of the present investigation was to develop a site-specific colonic drug delivery system, built on the principles of the combination of pH and time sensitivity. Press-coated mesalamine tablets with a coat of HPMC E-15 were over-coated with Eudragit(R) S100. The in vitro drug release study was conducted using sequential dissolution technique at pH 1.2, 6.0, 7.2 and 6.4 mimicking different regions of gastrointestinal tract. The optimized batch (F2) showed less than 6% of drug release before reaching colonic pH 6.4 and complete drug release was obtained thereafter within 2 hr. A short-term dissolution stability study demonstrated statistical insignificant difference in drug release.
AAPS PharmSciTech. 2007 ;8 (3):E68 17915818 (P,S,G,E,B,D)
A novel solid dosage form of rifampicin and isoniazid with improved functionality.
[My paper] Mukesh C Gohel, Krishnakant G Sarvaiya
The aim of the present investigation was to develop a novel dosage form of rifampicin and isoniazid to minimize degradation of rifampicin in acidic medium and to modulate the release of rifampicin in the stomach and isoniazid in the intestine. Gastroretentive tablets of rifampicin (150 mg) were prepared by the wet granulation method using hydroxypropyl methylcellulose, calcium carbonate, and polyethylene glycol 4000. The granules and tablets of rifampicin were characterized. Hard gelatin capsules (size 4) containing a compacted mass of isoniazid (150 mg) and dicalcium phosphate (75 mg) were enteric coated. Two tablets of rifampicin and 1 capsule (size 4) of isoniazid were put into a hard gelatin capsule (size 00). The in vitro drug release and in vitro drug degradation studies were performed. Rifampicin was released over 4 hours by zero-order kinetics from the novel dosage form. More than 90% of isoniazid was released in alkaline medium in 30 minutes. The results of dissolution studies with the US Pharmacopeia XXIII method revealed that a substantial amount of rifampicin was degraded from the immediate release capsule containing rifampicin and isoniazid powder owing to drug accumulation in the dissolution vessel and also to the presence of isoniazid. The degradation of rifampicin to 3-formyl rifampicin SV (3FRSV) was arrested (3.6%-4.8% degradation of rifampicin at 4 hours) because of the minimization of physical contact between the 2 drugs and controlled release of rifampicin in acidic medium in the modified Rossett-Rice apparatus. This study concludes that the problem of rifampicin degradation can be alleviated to a certain extent by this novel dosage form.
AAPS PharmSciTech. 2007 ;8 (1):9 17408231 (P,S,G,E,B,D)
Preparation and assessment of novel coprocessed superdisintegrant consisting of crospovidone and sodium starch glycolate: a technical note.
[My paper] Mukesh C Gohel, Rajesh K Parikh, Bansari K Brahmbhatt, Aarohi R Shah
Department of Pharmaceutics, L. M. College of Pharmacy, Navrangpura, Gujarat, Ahmedabad, India. mukeshgohel@hotmail.com
J Pharm Pharm Sci. 2005 Apr 16;8:76-93 15946601 (P,S,G,E,B)
A review of co-processed directly compressible excipients.
[My paper] M C Gohel, Pranav D Jogani
Direct compression is the preferred method for the preparation of tablets. The present review outlines the importance of the functionality of the directly compressible adjuvants in the formulation of tablets. The co-processing is the most widely explored method for the preparation of directly compressible adjuvants because it is cost effective and can be prepared in-house based on the functionality required. Hence, the present review focuses on the properties of the co-processed directly compressible adjuvants available in the market.
AAPS PharmSciTech. 2000 ;1 (4):E31 14727896 (P,S,G,E,B)
Novel mathematical method for quantitative expression of deviation from the higuchi model.
[My paper] M C Gohel, M K Panchal, V V Jogani
Department of Pharmaceutics, L.M. College of Pharmacy, P.O. Box. No. 4011, Navrangpura, Ahmedabad-380009, India. mukeshgohel@hotmail.com
A simple mathematical method to express the deviation in release profile of a test product following Higuchi's kinetics from an ideal Higuchi release profile was developed. The method is based on calculation of area under the curve (AUC) by using the trapezoidal rule. The precision of prediction depends on the number of data points. The method is exemplified for 2 dosage forms (tablets of diltiazem HCl and microspheres of diclofenac sodium) that are designed to release the drug over a 12-hour period. The method can be adopted for the formulations where drug release is incomplete (<100%) or complete (100%) at last sampling time. To describe the kinetics of drug release from the test formulation, zero-order, first-order, Higuchi's, Hixson-Crowell's, and Weibull's models were used. The criterion for selecting the most appropriate model was based on the goodness-of-fit test. The release kinetics of the tablets and microspheres were explained by the Higuchi model. The release profiles of the test batches were slightly below the ideal Higuchi release profile. For the test products, observed percentage deviation from an ideal Higuchi profile is less than 16% for tablets and less than 11% for microspheres. The proposed method can be extended to the modified release formulations that are designed to release a drug over 6, 18, or 24 hours. If the data points are not evenly separated, the ideal drug release profile and AUC are calculated according to the specific sampling time. The proposed method may be used for comparing formulated products during the research and development stage, for quality control of the products, or for promoting products by comparing performance of the test product with that of the innovator's product.
Mesh-terms: Chemistry, Pharmaceutical :: trends; Delayed-Action Preparations :: chemistry; Delayed-Action Preparations :: metabolism; Kinetics; Models, Theoretical; Tablets :: chemistry; Tablets :: metabolism;
Pharm Dev Technol. 2003 ;8 (4):323-33 14601957 (P,S,G,E,B)
Studies in preparation and evaluation of pH-independent sustained-release matrix tablets of verapamil HCl using directly compressible Eudragits.
[My paper] Mukesh C Gohel, Tejas P Patel, Shital H Bariya
Department of Pharmaceutics and Pharmaceutical Technology, L.M. College of Pharmacy, Ahmedabad, Gujarat, India. mukeshgohel@hotmail.com
The objective of the present study was to investigate the impact of formulation factors on the properties of a 12h modified-release formulation of verapamil HCl. A 2(3) full factorial design was employed to investigate the influence of amount of Eudragit RS PO/RL PO (X1, a matrixing agent), HPMC K4M (X2, an auxiliary matrixing agent cum binder) and PEG 4000 (X3, channelling agent cum plasticizer). The tablets were prepared by direct compression and they were evaluated for in vitro dissolution studies in 0.1 N HCl. The time required for 90% of the drug release (t90) and similarity factor (f2) were used as responses for the selection of most appropriate batches. Swelling and fluid penetration studies were carried out in 0.1 N HCl. Time required for 90% of the drug release (t90) was calculated by using an appropriate kinetic model for each batch. An ideal drug release profile (i.e., 25% in the first hour and a constant drug release thereafter) was considered as a reference release profile for calculation of f2. Multiple regression analysis was adopted to evolve refined models for t90. The required release pattern was shown by batches containing a low level of Eudragit RS PO/RL PO (30% w/w), low level of HPMC K4M (10% w/w), and high level of PEG 4000 (15% w/w). Response surface plots are shown for t90. These formulations showed slower drug release in alkaline medium (pH 7.2). Succinic acid and KH2PO4 were incorporated in the matrix in order to obtain pH-independent drug release. Swelling of tablets and fluid penetration in the matrix were found to be influenced by the selected independent variables. This study demonstrates that the desired drug release pattern can be obtained by adopting a systematic formulation approach.
Drug Dev Ind Pharm. 2003 May ;29 (5):565-74 12779286 (P,S,G,E,B)
Development of modified release diltiazem HCl tablets using composite index to identify optimal formulation.
[My paper] M C Gohel, M M Patel, A F Amin
Department of Pharmaceutics and Pharmaceutical Technology, L. M. College of Pharmacy, Navrangpura, Ahmedabad, India. mukeshgohel@hotmail.com
This article reports the preparation of tartaric acid treated ispaghula husk powder for the development of modified release tablets of diltiazem HCl by adopting direct compression technique and a 32 full factorial design. The modified ispaghula husk powder showed superior swelling and gelling as compared to untreated powder. Addition of compaction augmenting agent such as dicalcium phosphate was found to be essential for obtaining tablets with adequate crushing strength. In order to improve the crushing strength of diltiazem HCl tablets, to modulate drug release pattern, and to obtain similarity of dissolution profiles in distilled water and simulated gastric fluid (pH 1.2), modified guar gum was used along with modified ispaghula husk powder and tartaric acid. A novel composite index, which considers a positive or a negative deviation from an ideal value, was calculated considering percentage drug release in 60, 300, and 540 min as dependent variables for the selection of a most appropriate batch. Polynomial equation and contour plots are presented. The concept of similarity factor (f2) was used to prove similarity of dissolution in water and simulated gastric fluid (pH 1.2).

Pharm Dev Technol. 2003 ;8 (2):143-51 12760565 (P,S,G,E,B)
Development of agglomerated directly compressible diluent consisting of brittle and ductile materials.
[My paper] Mukesh C Gohel, Pranav D Jogani, Shital E H Bariya
Department of Pharmaceutical Technology, L.M. College of Pharmacy, Navrangpura, Ahmedabad, India. mukeshgohel@hotmail.com
The objective of this investigation was to develop a novel multifunctional coprocessed adjuvant consisting of three known diluents that show different consolidation mechanisms. The method of wet granulation was adopted for the preparation of coprocessed product. Microcrystalline cellulose (MCC) and colloidal silicon dioxide (X1), lactose monohydrate (X2), and dibasic calcium phosphate dihydrate (X3, DCP) were used as independent variables in a simplex lattice design. Croscarmellose sodium was used at 4% level intragranularly in all the batches. The granules (44/120 #) were characterized for angle of repose, bulk density, tapped density, and Carr's index. The tablets of coprocessed adjuvants were characterized for crushing strength, friability, and disintegration time. Multiple linear regression was adopted for evolving refined mathematical models. A checkpoint batch was prepared and evaluated for particle size distribution, moisture uptake, and dilution potential by using nimesulide as a model drug. Microcrystalline cellulose shows poor flowability due to irregular shape and interlocking. Moreover, it loses a part of its compactibility on wet granulation. To attend these problems, a physical blend of 97% microcrystalline cellulose and 3% colloidal silicon dioxide M5 was prepared and used. The blend of MCC and colloidal silicon dioxide showed better flow than that of the original MCC. Hence, it may be easier to mix with lactose and dibasic calcium phosphate. The loss in compactibility of microcrystalline cellulose on wet granulation was also reduced due to presence of colloidal silicon dioxide. As expected, all the batches exhibited acceptable angle of repose (<35 degrees) and quick disintegration (<1 min). Full and refined models for Carr's index and crushing strength were evaluated. Based on the results of grid analysis, a checkpoint (50% MCC, 40% lactose, and 10% DCP) that satisfies both the conditions of Carr's index and crushing strength was selected. The adjuvants absorb very little moisture in the moisture uptake study. The results of dilution potential study reveal that up to 30% nimesulide, a poorly compressible drug, can be incorporated in the coprocessed product. In vitro drug dissolution from capsules containing pure drug powder and compressed tablets was comparable (f2 = 79). The results reveal that the desired product characters can be obtained by varying the quantity of MCC (a ductile material that undergoes plastic deformation), lactose (brittle material with low-fragmentation propensity), and DCP (brittle material with high-fragmentation propensity).
Mesh-terms: Adjuvants, Pharmaceutic :: chemistry; Calcium Phosphates; Cellulose; Chemistry, Physical; Excipients :: chemistry; Hardness Tests; Lactose; Particle Size; Silicon Dioxide; Solubility; Starch; Sulfonamides :: administration & dosage; Sulfonamides :: chemistry; Support, Non-U.S. Gov't; Tablets; Water :: chemistry;
Drug Dev Ind Pharm. 2003 Mar ;29 (3):299-310 12741611 (P,S,G,E,B) Favorite:1
Processing of nimesulide-PEG 400-PG-PVP solid dispersions: preparation, characterization, and in vitro dissolution.
[My paper] M C Gohel, L D Patel

Pharmaceutics and Pharmaceutical Technology Department, L. M. College of Pharmacy, Navarangpura, Ahmedabad, India. mukeshgohel@hotmail.com
The objective of this investigation was to study the influence of dissolution enhancers such as polyethylene glycol 400, propylene glycol, polyvinylpyrrolidone K30, sodium lauryl sulfate, and Tween 80 on in vitro dissolution of a model active pharmaceutical material--nimesulide. Preliminary studies were conducted using a physical blend of nimesulide, and the adjuvants and solid dispersions were prepared using solvent evaporation and cogrinding methods. Aqueous solution of adjuvants was first triturated with nimesulide, followed by mixing with lactose and microcrystalline cellulose, and finally water was evaporated under vacuum in a cogrinding method. A 33 factorial design was adopted in a cogrinding method using the concentration of polyethylene glycol 400, propylene glycol, and polyvinylpyrrolidone K30 as independent variables. Tween 80 and sodium lauryl sulfate were added in all the batches. Full and reduced models were evolved for different dependent variables. The reduced models were validated using two checkpoints. Angle of repose < 35 degrees, percentage of drug released in 30 min (Q30) > 40%, 45 min (Q45) > 50%, and 120 min (Q12) > 60% were used as constraints for the selection of an optimized batch. Contour plots are presented for the selected dependent variables. Polyvinylpyrrolidone was found to be more effective in increasing the drug dissolution, compared with polyethylene glycol 400 and propylene glycol. The granule flow was adversely affected when high levels of liquid adjuvants were used in formulations. Wettability study was conducted to measure wetting time for pure drug and the optimized batch. Improved drug dissolution was attributed to improved wetting and the solubilizing effect of adjuvants from the pseudosolid dispersions of nimesulide. Significant improvement in drug dissolution was observed (Q120 = 70%), compared with pure drug powder (Q120 = 15%). In conclusion, dissolution of nimesulide can be modulated using an appropriate blend of pharmaceutical adjuvants.

Boll Chim Farm. ;141 (1):21-8 12064053 (P,S,G,E,B)
Studies in release behavior of diltiazem HCl from matrix tablets containing (hydroxypropyl)methyl cellulose and xanthan gum.
[My paper] M C Gohel, A F Amin, K V Patel, M K Panchal
Department of Pharmaceutics and Pharmaceutical Technology, L. M. College of Pharmacy, Navrangpura, India.
(Hydroxypropyl)methyl cellulose and xanthan gum were used as hydrophilic matrixing agents for preparing modified release tablets of diltiazem HCl. The amount of (Hydroxypropyl)methyl cellulose and xanthan gum exhibited significant effect on drug release from the tablets prepared by direct compression technique. Xanthan gum showed a higher ability to retard the drug release than (Hydroxypropyl)methyl cellulose. A 2(2) + 1 factorial design was adopted to study the effect of amount of (Hydroxypropyl)methyl cellulose and xanthan gum on percent drug released in first hour (Y60) and the time required for 90% drug dissolution (t90). A response surface plot is generated for investigating the effect of the independent variables on t90. The tablets containing 90 mg diltiazem HCl, 45 mg (Hydroxypropyl)methyl cellulose and 45 mg xanthan gum showed drug release upto 12 h. The value of similarity factor, f2, for the selected batch was found to be 85.1 when the dissolution study was carried out in water or simulated gastric fluid, indicating pH independent drug dissolution. The selected batch also showed a comparable release profile with a market product (f2 = 60.2). Linear relationship was observed between percent drug released and degree of swelling. The kinetics of the drug release fitted well to the Hixson-Crowell equation. It can be concluded that by using a suitable blend of (Hydroxypropyl)methyl cellulose and xanthan gum desired modified drug release can be achieved.

List of Granted Patents

1. A novel method of preparation of mouth dissolve tablets of nimesulide from granules prepared by

eutectic blend

Inventors: Dr. Mukesh Gohel and Dr. S. P. Adeshara

Application Number: 580/mum/2002,

Patent Number : 207051

Date of filing: 1-7-2002

Status: The patent is granted

2. Process for preparation of directly compressible adjuvant of sodium bi carbonate

Inventors: Dr. M. C. Gohel and Pathik Brahmbhatt

ApplicationNo. : 846/mum/2002

Patent Number : 195981

Date of filing: 27-9-2002

Status: The patent is granted

3. A novel hard gelatin capsule shell and method of preparation thereof

Inventors: Dr. M C Gohel and Mr. R K Parikh

Application No: 820/mum/2003

Patent Number : 207771

Date of filing: 18-8-2003

Status: The patent is granted

4. Process to manufacture dispersible tablet

Inventors: Dr. Mukesh Gohel and Alpa Chavada

ApplicationNo: 925/mum/2003

Patent Number : 205370

Date of filing: 8-9-2003

Status: The Patent is granted

5. A novel method of preparation of hard capsule shell

of preparation thereof

Inventors: Dr. M C Gohel and Mr. R K Parikh

ApplicationNo: 956/mum/2003

Patent Number : 206669

Date of filing: 15-9-2003

Status: The patent is granted

6. A novel Swertiamania compound and method of isolation of swertiamania from

plant enicosteman littorane and its antibacterial activity

Dr. R. K. Goyal and Santosh Vishwakarma

Application Number: 1028/MUM/2003

Patent Number : 197900

Status: The patent is granted

7. A novel formulation of chromium insulin injection (suspension) and its

Preparation

Dr. R. K. Goyal, Dr. Ajmeer Ramkishan and Dr. Mukesh C. Gohel

Application No. 1120/MUM/2006

Patent Number: 208600

Status: The patent is granted

8. A novel capsule of active pharmaceutical ingredients

Dr. M. C. Gohel and Dr. R. K. Parikh

Application No. 72/MUM/2004

Date of filing 15/9/2003

Patent Number : 213330

Status: The patent is granted

9. Hard capsule shell consisting of gelatin and HPMC and novel method of

preparation thereof

Dr. M. C. Gohel and Dr. R. K. Parikh

Application No. 819/MUM/2003

Date of filing 18/8/2003

Patent Number : 234704

Status: The patent is granted

History

Member for
7 years 4 months

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