Redesigning of drug in Unani Formulations
Unani System of Medicine (USM), prescribes elaborate pharmaceutical processing of drugs to achieve palatability, stability absorption and assimilability, and to enhance the safety and efficacy of drugs. These objectives are obtained not only by developing various dosage forms on rationale and experimental bases but also by devising many processing (Tadabeer) techniques. This pharmaceutical processing is applied to both single (single ingredients) preparations and compound (multiple ingredient) preparations. It also has a unique speciality of adding corrective drugs (musleh advia) to counter the toxicity of main drugs. Now a days these drugs are being manufactured mostly in the classical form. Modern instruments are used in preparation of drugs. Sometimes minor alterations are made in the dosage form and due care in mind not to depart from the original essence. GMP (Good Manufacturing Practices) are followed in order to ensure quality of these drugs.
Unani medicine since its origin passed through many stages, countries, cultures and civilizations. It contains not only Greek, Roman, Egyptian, Arabic, Persian and Indian origin drugs and formulations but from several parts of the world. So wide variety of drugs/ mixture of drugs from different parts of world is available in Unani texts. It is duty of Unani medicine physicians/ experts to prescribe best treatment through best available drugs to the suffering humanity. Ilmul Advia (Unani Pharmacology) is an important wing of Unani system of Medicine. It is related to the identification of drugs, their pharmacological actions and uses of Mufradat (single drugs) as well as Murakkabat (compound formulations). It also includes Saidla (Unani Pharmacy) which guides in proper way to prepare Murakkabat (compound formulations).
What is Drug Designing
Drug designing is one of the major concerns in any system of medicine as it is not just the efficacy and potency of any drug formulation that plays a pivotal role, but shape, taste, colour etc. also plays an important role in the intake of any medicine. This becomes more concerning in our Unani System of Medicine (USM) in the present era with special emphasis on Unani Drug Formulations.
Drug design also known as rational drug design or rational design is an splendid inventive process of new medication on the basis of biological targets. That is the invention in medical history in order to yield significant therapeutic response which enhances the therapeutic benefits of new drugs.
All other System of Medicines has modified their formulation according to the need, but in USM formulations are maintained at the same stage as they were discovered. We cannot deny the formulations made by our eminent Unani Formulations, but we need to change them according to the need today e.g Diabetes is now one of the major prevalent disease that has been now more common, so if we continue using our Unani Formulations as Majoon, Khameera, Jawarish etc. which contains 70-80% Sugar in it; it will definitely worsen the condition; and this is one of the profound reason of Why USM is not exercised at a level where it should be. Although Sugar in these type of formulations used was due to their preservation, taste correction, etc. but when it is worsening we need to search for some alternatives from natural flora which can cover up the preservation or taste etc. Such case is not only due to Sugar inclusion but Safoof (Powder) used in USM is very difficult to take, similarly Hab (Pills) or Qurs (Tablet) get broken up easily and got scattered away during storage only. Present paper will include a brief discussion on the problems arising in USM formulations and possible alternatives to solve such problem to an extent.
Scope of Redesigning of Unani Drugs
It has wide scope to study as well as research. As it includes evaluation identification, cultivation, collection, storage etc) of Mufradat (single drugs) and Murakkabat (compound formulation) on one hand and on the other hand their action and uses. In relation to Pharmacognosy, Pharmacology and pharmacy of modern stream it is much wider and this single discipline comprises Kulliyat Advia (Principles of drugs), Mufradat (Single drugs), Morakkabat (Compound formulations) and Saidla (pharmacy).
Scope in Doses forms of particular formulations
Doses forms of Unani drugs have been developed to achieve the basic objectives of pharmaceutical processing of drugs i.e. palatability, stability, assimilability and the enhancement of safety and efficacy.
In Unani system of medicine, drugs are used mainly in four forms. Mostly these drugs are used orally.
In addition to oral drugs Unani scholars also administer the drugs locally through sitz bath (Aabzan), enema (Huqna), suppository (Shiyaf), Pessary (Firzaja), liniment (Tila) etc.
Specific Processing of Unani drugs
Unani physicians were well aware that the fourth degree drugs drawn from plants, animal and minerals/ metal sources are highly harmful and toxic in nature. However, after proper processing they become safe enough for therapeutic uses.
The objectives of processing of drugs are not limited to detoxification but also include pharmacokinetic optimization (achievement of desirable rate of absorption, delivery to target tissues etc.) and efficacy enhancement.
Many innovative techniques are used for the processing of drugs in Unani system of medicine.
Standardization and Quality Assurance of Unani Drugs
In respect to the standardization and quality assurance of Unani drugs several methods have been developed. Government of INDIA has taken several steps to monitor the quality of these drugs. Government has introduced GMP (Good Manufacturing Practices) under schedule “T” of the “Drugs and Cosmetics Act, 1940”. Besides, this act also regulates the manufacturing and marketing of Unani drugs. The said act also ensures that the raw materials used in the manufacturing are authentic as per prescribed standards and norms.
Drug standardization and quality assurance is mainly concerned for the development of pharmacopoeial standards of single and compound Unani drugs included in National Formulary of Unani Medicine or other available Unani drugs.
Ministry of AYUSH in collaboration with QCI (quality Council of India) has developed a scheme for certification of assurance of quality in AYUSH products. NABL (National Accreditation Board for Testing and Calibration Laboratories) and NABH (National Accreditation Board for Hospitals and Healthcare providers) have been stablished by Government of INDIA for this purpose. These laboratories are approved for quality testing of Unani drugs.
A part from that PCIM (Pharmacopoeia commission for Indian medicine) has been stablished in 2010 to develop pharmacopoeial standard for Ayurveda, Unani and Siddha drugs for promotion of quality and safety of these drugs. In this regard Unani pharmacopoeia committee is constituted by the PCIM for developing pharmacopoeial standard of Unani drugs.
Need of Research and development
Unani system of medicine comprises certain branches and Unani pharmacology (Ilmul Advia) is one, which plays pivot role in it. It is related to identification, action and uses of Mufredat (single drugs) as well as Murakkabat (compound formulations). It also includes Saidla (Pharmacy) which guides in proper way to prepare Murakkabat (compound formulation). It has wide scope for study as well as research. As it includes evaluation, identification, cultivation, collection, storage etc.) of Mufradat (single drugs) and Murakkabat (compound formulation) on one hand and on the other hand their action and uses. In relation to Pharmacognosy, Pharmacology and pharmacy of modern stream it is much wider and this single discipline comprises Kulliyat Advia (Principles of drugs), Mufradat (Single drugs), Morakkabat (Compound formulations) and Saidla (Pharmacy).
It is ancient system and work on its reserch is being done very little. Abu Bakar Muhammad Bin Zakariya Razi a renowned Unani Scholar said: It is very dangerous that a clinician ignores its own opinion and follows only literary prescription and others ideas. He also mentioned in his book that “life of a Person is not enough to know the efficacy and use of herbs”. So it is appropriate to use such drugs, which are used earlier, the drugs not available or less available are better not to use them. It needs research work if we consider this matter seriously we can divide broadly in following research areas.
Identification of drugs in Unani literature
Drugs are described in similarities. As if a particular drug is described in term of other particular drugs/things, which was popular in those days but now that is unpopular and even untraceable. There is urgent requirement to describe these on currently accepted binomial name, synonymous, vernaculars, Mizaj (temperament) the part of plant used, for each parameter for each preparation and detailed instruction for agricultural production and collection condition harvesting and storage according to the each country’s good agricultural practices. Some drugs like Afsanteen (Artemisia absynthium) is either not found or difficult to find authentic drug in the market or other species are present, so we should replace it or genuine drug should be obtained. like this, adulteration in Suddab (Ruta graveolance), Chiraita (Swertia Chirata), Kasoos (Cuscuta reflexa Cassia acutifolia), Biskhapra (Trianthema portulastrum), Baobarang (Embelia ribes), Banafshah (Viola odorata), Senna (Cassia angustifolia from its adulterant Cuscuta chinensis) must also be checked and properly identified. So authentic drug may be used and adulteration should be checked. A lot of potential species are available for adulteration of crude and processed Phyllanthus emblica fruits. The adulterant may be phylogenetically close or distinct (e.g. dried fruit pieces of pumpkin) from Phyllanthus emblica. Pueraria tuberosa, commonly known as Vidarikand in India, is an important plant used in traditional medicine. However, there are at least three other botanical entities traded under the same name, namely Ipomoea mauritiana, Adenia hondala and Cycas circinalis.
Research about action and uses of particular drugs
A lot of research work is required/ needed to be done in relation to the actions and uses of Unani drugs, which should depend on the nature and level of the indication. The level of the evidence and the grading of recommendation must correspond to nature of illness to be treated or the nature of the physical or mental function to be treated or the nature of physical or mental function to be influenced and regulated.
The drugs, which are used in Unani formulations, need again to be trialled and evaluated scientifically. It is said that Asgand Nagauri (Withania somnifera) found in a Nagaur region, has better result.
Modification in Doses of Drugs:
The dose of drug is also needed to be modified when used in some prescriptions or used as single drugs, like some doses are to be taken in bulk quantity. Furthermore preparation should be made in such form, which may be used in minimum dose with high efficacy.
Murakkabat (compound formulation)
It should be noted that Unani drugs are herbal- minero- animal in origin. A scientific or therapeutic rationale must exist for the presence of each herb in the mixture.
Research requirements about ingredients of Compound preparations
There are certain preparations, which contain more ingredients.
Research requirements in preparation method of drugs
Now a days we are living in computer age. We should prepare drugs on modern standardized parameters with Unani medicine concept, to compete the world. The computer based drug redesigning is an emerging area of scientific research with great importance. The knowledge abstraction for achieving the goals of this research is not only limited to modern chemistry or pharmacy. The computational scientists are ready to widen their knowledge based on all branches of medicines and we can also find relevant and significant information from traditional systems of medicine like Unani medicine.
For example, in preparation of Kushtajat, heat should be given in terms of temperature regulated by electronic methods but still now it is being done in terms of weight of dung cake. Also there are sophisticated powdering machines available in markets. Instead of these machines we use Kharals for powdering the drugs.
We should also consider the different parts and form of preparation. For example Arusa is very much used in different ailments of lungs. We use it in form of sharbet (syrup), Joshanda (decoction) but as indicated in literature its Rub, Usara, Namak, Gulqand, etc must also be prepared and clinically tested/ trialled for efficacy. If results are encouraging and dose is reduced, we must encourage such preparation.
Time of preparation is very important; as in Unani literature, Joshanda is indicated to boil till water remains half or 1/3rd or ¼th, there should be clear indication of time and temperature of boiling.
In preparation method steps should be established and at that time these processed drug should be evaluated. For example, when Joshanda is soaked in water for 24 hours then after 24 hours and finished preparation its marker should be established. It will help to make hypothesis in other products for further research.
In the preparation of kushta of Para (mercury) there is a stage of kajli and product, should be evaluated.
Sharbat (Syrup), Majun (Semi solid preparation) and many other preparations of Unani medicine, sugar should also be replaced to other non-harmful sugars, which will be safe to diabetic patients.
Toxicity (Sammi asaraat) study of Unani drugs must be done. In this regard a review of the literature should identify the current level of evidence for the safe and effective use of Unani medicine. For example toxicity study of “Kushtajat” and other poisonous drugs should be evaluated, so that limitations, indications, contraindication may be established.
The study design should be evaluated, taking note of, for example, the number of patients, specific diagnosis, dosage, duration of administration, criteria for evaluation (such as improvement of symptoms) absence of simultaneous therapy, and valid statistical analysis.
Muzir (Harmful effect) and Musleh (Correctives of harmful effects) is also described in Unani books as this particular drug is harmful for hot temperament people or harmful for stomach (Garm Mizaj mein muzir, Muzirr-e- Meda) but there is no particular basis or pattern developed. It should be clear that particular drug is toxic or has side effect or after effect in such a way to clear the facts. Uses of certain corrective (Musleh advia jaat) are recommended in such cases
It is need of time to evaluate/ validate Unani drugs on latest modern available parameters, if they are applicable maintaining Unani System of medicine’s principles.
It is concluded that compound formulations (Advia Murakkaba) have very vast field to do research and clinically validate them. It is the duty Unani scholars and those having faith in this traditional system of medicine to come forward to accept challenges of modern time and establish new field of research not only of single drugs but in compound drugs.
Reverse pharmacology should be thoroughly considered to reduce the number of ingredients of particular compound for better efficacy with consideration of cost to take this system on its peak as it was in past times.