Recent Advances in the Chemical, Manufacturing and Regulatory Aspects of Phytopharmaceuticals

 

Dr. Shoaib Ahmad

University School of Pharmaceutical Sciences, Rayat-Bahra University, Mohali 140104 India

ABSTRACT:

Phytopharmaceuticals are now a part of the alternative therapeutic systems. In the earlier days, the scientific community had certain reservations on using the non-standardized medicinal plant products. With the advent of the era of sophisticated instrumentation in chromatography and spectroscopy, research has also focused on the phytopharmaceuticals. The hyphenated techniques such as LC-MS, GC-MS, HPTLC-MS etc have better accuracy, reproducibility and sensitivity. Hence, such techniques are used to identify and quantify the chemical constituents of the phytopharmaceuticals. St. John’s Wort, Milk thistle and Ginkgo represent one of the successful phytopharmaceuticals. There are hundreds of medicinal plants which are yet to be explored for phytopharmaceuticals. The bioactives are being identified using the analytical instrumentation techniques. There have also been talks about the concept of synergy amongst the medicinal plant components. In many cases, it has been reported that the isolated chemical constituents are devoid of the pharmacological effects which were previously seen in the extracts or combination of medicinal plant products. Pharmaceutical industry is one of the largest consumers of the phytopharmaceuticals and it is trying to increase the yield of bioactives in the medicinal plants – often by biotechnological intervention. Of late, the regulatory authorities have started recognizing the phytopharmaceuticals as a separate class. It is hoped that in the coming days, the pharmaceutical technology and nano-technology will be able to contribute productively in the area of phytopharmaceuticals. The present paper is aimed at giving an overview of the chemistry, manufacturing and regulatory aspects of phytopharmaceuticals.

 

 

 

INTRODUCTION:

Plants have been used since times immemorial as food, medicine and non-medicinal commercial purposes. The various systems of medicine (including orthodox medicine, ayurveda, homeopathy, Unani Tibb, herbal medicine, Siddha, traditional Chinese medicine and other forms of medicinal systems) have relied to a great extent on medicinal plants. Medicinal plants have a long history of documented and undocumented usage by human civilizations across the globe.

 

Phytotherapy has solely relied on use of medicinal plant products. Commonly, plants are used in the form of extracts and bioactives. There has been a trend to standardize the botanicals and phytopharmaceuticals. Many pharmaceutical companies are marketing standardized extracts. Phytopharmaceuticals are a trend in themselves and have almost been the part of history of traditional medicine¹.

 

Silymarin-containing phytopharmaceuticals are also reported to be popular². St. John's Wort is an important source of phytopharmaceuticals³. A taxonomic group of 500 species, genus Ardisia has been described to be a new source of phytopharmaceuticals⁴. Ginkgo biloba phytopharmaceuticals have been comprehensively reviewed⁵. History of phytopharmaceuticals usage has been documented⁶.

Chemistry and Analysis

Black radish yield several phytopharmaceuticals⁷. Ginkgolic acids is found in leaf extracts and phytopharmaceuticals from Ginkgo biloba Linn.⁸ Flavonoids have determined to be active in Ginkgo biloba L. and its phytopharmaceuticals. These flavonoids include epicatechin, catechin, rutin, apigenin, luteolin, and quercetin⁹. Ginkgolides and bilobalide are estimated in phytopharmaceuticals using liquid chromatography-mass spectrometry (LC-MS)¹⁰. Frankincense gum also finds utility as phytopharmaceuticals and its triterpenic acids are characterized using HPLC-PDA¹¹. Quercetin and kaempferol commonly occur in phytopharmaceuticals and can be estimated using numerous chromatographic and electrochemical methods¹². Flavonoids and terpene lactones in Ginkgo biloba L. phytopharmaceuticals have been identified using HPLC¹³.

 

'Guarana' based phytopharmaceuticals have been analysed using capillary electrophoresis and HPLC¹⁴. Three flavonols - quercetin, kaempferol, and isorhamnetin – have been identified in in Hippophae rhamnoides phytopharmaceuticals by HPLC¹⁵. Cinchonain Ib has been identified in phytopharmaceuticals of Trichilia catigua by HPLC¹⁶. Antioxidants in Nigella sativa L.) phytopharmaceuticals have been quantified using HPLC¹⁷. HPLC-DAD has been used for estimating antioxidants and caffeine in phytopharmaceuticals¹⁸. Metabolic fingerprinting based on MS and NMR has a definite role in the quality control of phytopharmaceuticals¹⁹.

 

Production and Regulatory Aspects:

Synergy research in phytopharmaceuticals has also attracted the attention of scientific community^20-21. DNA barcoding may be used for exact identification of plant species and hence, play an important role in development of better phytopharmaceuticals²². Pre-formulation of Ayurvedic phytopharmaceuticals has also been reported²³. Phytosome are debated to be an efficient formulation of phytopharmaceuticals²⁴. Contemporary approaches in phytopharmaceuticals production by use of plant biotechnology have been discussed²⁵. Biotechnological yield of phytopharmaceuticals has also been a matter of discussion²⁶. Pharmaceutical nanotechnology may soon help in expansion of phytopharmaceuticals, herbal extracts and bioactives²⁷. Drugs and cosmetics rules in India needed amendment(s) in case of phytopharmaceuticals²⁸. Phytopharmaceuticals are now regulated in India²⁹.

 

CONCLUSIONS:

Phytopharmaceuticals are certainly a boon for the ailing people in the developed and developing countries. Despite sufficient progress in the analytical technologies and instrumentation, there are many areas which require attention in phytopharmaceuticals. These areas include: formulation, pharmacology, drug delivery, safety and efficacy of the phytopharmaceuticals.

 

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Received on 15.07.2017       Accepted on 28.09.2017     

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