Biotechnology Company Products Overview and Analysis

CHAPTER 1- Introduction

In 1906, Hakeem Hafiz Abdul Majeed laid the foundation of Hamdard Dawakhana in Delhi. It was initially started as a small Unani clinic in the historic by lanes of Old Delhi. Hamdard is known for its integrity and high quality in the field of Unani medicines.

The goal of Hamdard was to ease the sufferings of the sick using the healing properties of herbs. After Hakeem Abdul Majeed passed away at a younger age the reigns of the institutions were in the hands of his wife, Rabia Begum and his son Hakeem Abdul Hameed.

At Hamdard, it is believed that just adhering to traditional ways will not let them stand strong with time therefore they have invested in the world of discovery and research.

The major challenge for Hamdard was the various formulae given for one medicine in various pharmacopeias as there were no records of processing the medicine. But the obstacle was overcome through extensive research and widely recognized formulations.

Which were later standardized and indexed. This was then published as the Hamdard pharmacopoeia (Qarabadin- Hamdard)

Hamdard has also launched new medicines through its research and development of new technologies.

Vision and Mission

The mission of Hamdard is to become a worldwide medicinal organization by introducing branded and generic products in the key market.

They envision embodying global wellness through care, innovation and cultural growth to improve the lives of patients.

Leading Products of Hamdard

ROOH AFZA: Introduced in 1907, RoohAfza is a fruit-filled, friendly punch which is a perfect treat on a hot day.

It has been the country’s favorite drink for generations.

SAFI: It cleanses the blood from within by giving the liver, thyroid and the rest of the body the support they need and eliminates the toxins that usually cause acne and blemishes.

ROGHAN BADAM SHIRIN: Almond oil had been used widely for its health benefits and as a beauty utility much before science caught up with its goodness.

JOSHINA: It is used in nasty cold. Joshina helps clear up the stuffy nose and soothe scratchy throat.

SUALIN: A formulation of time-tested herbs, Sualin is a natural & effective remedy for sore throat, cough and hoarse voice.

ARQ GULAB: Cleopatra was believed to have used it as a part of her beauty regime, and for generations, rose has been used by women across the world to enhance their beauty.

PACHNOL: A natural digestive tablet, the chewable helps provide fast and effective relief from indigestion, hyperacidity, burning chest, nausea, vomiting, lack of appetite and pain and heaviness in the stomach after meals.

MASTURIN: A natural and wonderfully effective women’s health restorative. The herbs used in the product help women stay healthy and enjoy life to the fullest.

CINKARA: It restores lost energy, increases appetite, improves debility and conditions of fatigue and is effective in convalescence.

JIGREENA: Natural, complex multi-herb formulations ensure optimum liver function by virtue of its anti hepato toxic activity and help protect the liver against harmful toxins from drugs, alcohol, food and water.

NONIHAL GRIPE SYRUP: When a toddler has a stomach ache, it can be worrisome for both the child as well as the parent.

CHAPTER 2- Standardisation And Evaluation Of Botnical Raw Material

Standardization is the procedure of ensuring identity, quality and purity of herbal drugs. Since there are no clear guidelines about the standardization of drug in medicine systems like Ayurveda therefore it is necessary to promote drug standardization in the industry. With the commercialization of herbal medicine, assurance of safety, quality of medicinal plants and herbal products has become an imperative issue. The American Herbal Product Association defines standardization as “Standardization refers to the body of information and control necessary to product material of reasonable consistency. This achieved through minimizing the inherent variation of natural product composition through quality assurance practices applied to agricultural and manufacturing processes”. Following are the standardization parameters used for herbal drugs.

Sampling of the material in bulk

A sample is representation of whole batch. Thus sample analysis is important. A sample must be looked for any physical damage or moisture etc. Inspection of the sample must be done for

Organoleptic characteristics

Organoleptic characteristics include analysis on the basis of color, texture and odor by the means of sense.

Authentication of botanical raw material:

The first step in developing a plant product is authentication. Authentication is essential as harvest, storage, manufacturing and processing may alter the quality of raw material. Classical botanical methodologies are practiced for collection and documentation of the plant. The botanical origin of the drug is identified and its binomial i.e. genus species name is determined. Site of collection of plant material is done by plant botanist. The sample of collected material is kept as a voucher sample in herbarium for future references. The botanical parameter of standardization includes microscopy and macroscopy.

Macroscopy: Maroscopy is the visual inspection of the raw material based on shape, size, colour, surface characteristics, texture, fracture characteristics and appearance of the cut surface.

Microscopy: Under microscopy fresh parts of the plants and powder studies are done. Broken or powdered materials are difficult to inspect microscopically therefore chemical reagents are used to treat. Other analytical methods are also used, along with microscopy to provide complete identification.

Determining Foreign Matter

Any herbal material consisting of parts of plants other than those named with limits specified for herbal material or any organism mentioned in the specification of the concerned herbal material is known as foreign material. Minerals, not adhering to herbal material are also considered as foreign material like soil, stones, sand and dust.

Deterring of any foreign material is important to ensure that the herbal material is free from contamination. Impurities like moulds, insects, and animal contamination like excreta should be removed. Any signs of abnormal odour, discoloration should be detected along with other poisonous matters. Formulation of moulds is a common problem while storing therefore Special care must be taken care while storage of the herbal products to avoid contamination and inclusion of other foreign materials.

Determining Ash Value:

There are three different methods to measure the total ash value after the herbal material is ignited. They are total ash, acid ash and water soluble ash. The total ash procedure includes both physiological ash and non- physiological ash. The physiological ash is the residue of plant tissue whereas the non- physiological ash is the residue of extraneous matter like sand and soil.

The acid – insoluble ash is obtained post boiling the total ash with dilute hydrochloric acid and igniting the leftover insoluble matter. This method is used to measure the silica present with sand

The water- soluble ash is the difference between the total ash and residue which is left after treatment of the total ash with water.

Extractive Value

This method is made for materials for which there is no suitable chemical or biological assay. It determines the amount of herbal material. There are two methods that can be used, like hot extraction and cold maceration.

Determination of Volatile matter and water

Limits of water content is set for herbal material to ensure that there is no microbial growth, presence of fungi or insects due to excess water in herbal material. Excess water also leads to spoilage of the raw material as it tends to absorb moisture easily.

Determination of pesticide residues

The toxicology parameter for standardization includes determination of pesticide residues and heavy metals. Any particular substance in raw material due to the use of pesticide during agricultural practices such as spraying, behavior of soil during cultivation and addition of fumigants during storage is called pesticide residue. The pesticide residue is determined by column and gas chromatography and the limits should be established as per recommendations of the food and agriculture organization. In general the limits for pesticides residue in medicine is 45- 50.

Determination of heavy metals

Environmental pollution is one of the causes of arsenic and heavy metal contamination in medicinal plants. Presence of heavy metal can be determined using the standard solution and test solution procedure.

Determining Microorganism

Many countries have restricted the methods for decontamination. For instance the European countries have forbidden the use of ethylene oxide. Special registration procedure is required in many countries for treatment with ionizing irradiation

CHAPTER 3- Evaluation Parameters Used For Botanical Raw Material In Herbal Laboratory

CHEMICAL PARAMETRS

Water soluble extractive

• Taken 5g sample and place it in a bottle or conical flask.
• Add 100 ml distilled water and place it on magnetic stirrer for 3-4 hours
• Aliquot 20 ml in Petridis and place it on water bath for 20 minutes.
• After water bath place it in oven and leave it for 30 minutes after oven weight the Petridis.

Alcohol soluble extractive

• Take 5g sample and place it in a bottle or conical flask.
• Add 100 ml methanol and place it on magnetic stirrer for 3-4 hours.
• Aliquot 20 ml in Petridis and place it on water bath for 20 minutes.
• After water bath place it in oven and leave it for 30 minutes and finally weight the Petridis.

PHYSICAL PARAMETER

Loss of drying

• Weigh empty Petridis and then take weight of the sample i.e. 1gm of raw material.
• Then add weight of the Petridis and sample.
• Keep it in hot air oven for 3 hours at 105 degree Celsius.

CHAPTER 4- Evaluation Parameters Performed In Chemical Laboratory

Weight per ml.

• Take the weight of empty pycnometer.
• Weigh pycnometer and water
• Take the weight of pycnometer and sample.
• Put the value in the formula.

Ash content

• Take the weight of empty crucible
• Take 2g sample in crucible
• Placed on heater to remove the smoke then place in furnace and leave for three hours.
• Bring the crucible in decicator and take the weight

Ashless value

• To ash content result add 20 ml hcl (dilute)
• Normally heat on heater and filter using ash less filter paper.
• After filter leave for three hours in muffle furace.
• Bring it in decicator and finally take the weight.
• Calculation of acid value by titration.
• In burette take potassium hydroxide of strength- 0.1 M
• In conical flask take oil about 6g and add 20 ml of diethyl ether and 20 ml of ethnol and few drops of phenolphthalein as indicator.

Copper estimation

• Take 2g of sample and add 10ml of nitric acid
• Place it in sonicator for digestion and observe in uv spectrometer.
• Non aqueous titration of sodium citrate
• Assay-take 0.15g of sample and 20 ml of anhydrous glacial acetic acid and warm it to about 50 degree celsius and allow it to cool.
• Titrate it with 0.1 M per chloride acid, using0.25 ml of 1- naptholbenzin solution as indicator.

Estimation of calcium

• Take 0.05 M EDTA in burette and 0.1 g of calcium carbonate
• Add 3ml of dilute HCl and 15 ml of water.
• Let it evaporate it to 1 ml by placing it on heater. This is done so that calcium carbonate gets digested and all fumes and gasses are released.
• Next add 50ml of water and 8ml of sodium hydroxide. The indicator used is calcon mixture. Note the reading.

CHAPTER 5- Evaluation Parameters Used In Finished Products

In finished goods section the samples are tested on the bases of two types of factors. The factors on which the testing is based upon are as follows:-

CHEMICAL

LOD: LOD stands for loss on drying 10 gm. of drug was taken, spread uniformly and thin layered in a shallow Petridis. It was heated at a regulated temperature of 105 degree C, cooled in desiccators and weighed. The process was repeated many times till two consecutive weights were found constant. The percentage of loss in weight is always calculated with respect to initial weight taken of the sample.

Total Ash: Ash is the inorganic residue remaining after the water and organic matter have been removed by heating in the presence of oxidizing agents. 2.0032gm of drug was incinerated in a silica crucible of constant weight at a temperature not exceeding 450?C in a muffle furnace until free from carbon feaum after release the carbon fumes cooled and weight of crucible from weight of crucible + ash The instrument used in calculating the total ash is muffle furnace.

Water soluble extractive: 1gm of air dried drug, coarsely powered was macerated with 100ml of distilled water in closed flask for twenty four hours shaking frequently. Solution was filtered and 25 ml of filtrated was evaporated in a tarred flat bottom shallow dish, further dried at 100 C and weighted. The water soluble extractive percentage is calculated in reference to the air dried drugs.

pH: A functional definition of pH is the measurement of the acidity or alkalinity of a solution commonly measured on a scale of 0 to 14.In Finished goods section, testing of pH is done by checking the sample in two concentration 1% and 10%

pH of 1% solution: Dissolve an accurately weighed 1g of drug in accurately measured 100ml of water, and check the pH of sample with standardized glass electrode.

pH of 10% solution: Perform the experiment in the same manner as above taking 5g of sample and dissolve it in 50ml distilled water.

Brix: The concentration of sucrose not only affects the taste of the final product but also the aroma, shelf life, and potential for bacterial growth. Since sucrose is the most commonly used sugar in syrup products, sugar content is typically reported as percent Brix (% Brix) where one % Brix is equal to 1 gram sucrose per 100 grams of solution.

Refractive Index: It measures of the bending of a ray of light when passing from one medium into another. Different solutions are tested using refractometer and match with standard results.

Disintegration: It is a process in which tablets are break up into granules or smaller particles. So, disintegration test is a measure of the time required for a group of tablets to break up into particles under a given set of conditions. This test is essential for tablets intended for administration by mouth, except those intended to be chewed before being swallowed or those that should dissolve slowly in the mouth

METHOD

Place one tablet in each of the six tubes of the basket (tablets are selected randomly).

Position the basket rack in 1- L beaker containing distilled water (as the disintegration medium) maintained at 37 oC.Start the apparatus (to move the basket assembly containing the tablets), and record the time required for all of the six tablets to break into particles and to pass to the disintegration medium.

LIMIT

The tablets should disintegrate within 30 minutes (uncoated tablets). If one tablet fails to disintegrate within 30 minutes, the disintegration test is repeated on 12 additional tablets. Not less than 16 out of the total 18 tablets tested disintegrate completely within 30 minutes.

Uniformity:

It is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Tablets are selected randomly and an appropriate analytical method is applied to assay.

Diameter and Thickness:

The diameter and shape depends on the die and punches selected for the compression of the tablet. Usually the tablets are disc shaped but they may also be of other shapes like oval, oblong, round, cylindrical, or triangular. The upper and lower surfaces may be flat, round, concave or convex. Symbols or letters are often engraved on the surface of the tablet as an additional mean of identifying the source of the tablets. The color of the tablets is also used to tend to make them distinctive and identifiable.

Hardness (Crushing Strength )

Tablet hardness is the force required to break a tablet in a diametric compression test. Under this test, a tablet is placed between two anvils. Then the crushing strength that results the tablet to break is recorded.